Childhood ObesityNET-WorksNCT01606891
NET-Works:Community Preschooler Obesity Prevention
A study testing multi-component/setting parent-targeted intervention in people with Childhood Obesity, run by University of Minnesota at 1 site in United States.
Trial summary
The goal of the Minnesota center is to integrate primary care, home, and community-based intervention strategies to promote sustained patterns of change in food intake, physical activity, and body weight among low income, ethnically diverse children. Read more about this study
- Who is it for?
- Ages 2 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- multi-component/setting parent-targeted intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 534 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to 21 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A child and his or her parent(s) will be eligible for the study if:
- the two to four year old child is scheduled to receive or eligible for (based on an upcoming birthday) a recommended well child visit conducted by a pediatric or family practice care provider;
- the child has no medical problems that would preclude study participation as determined by the physician conducting the well child visit (e.g. serious disease that would make following guidelines for parent encouragement of healthy diet and physical activity infeasible);
- the child's BMI is greater than or equal to the 50th percentile according to CDC age and sex reference standards http://www.cdc.gov/nchs/data/nhanes/growthcharts/bmiage.txt;
- the child's parent/guardian agrees to participation in the study and is not planning to move out of the state in the next three years
- the primary caregiver is willing and able to complete the evaluation measures and participate in intervention activities if assigned to the active intervention group.
- the parent speaks either English or Spanish.
Who cannot join
- A child will be excluded if she or he does not meet the above eligibility criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Division of Epidemiology & Community Health
Minneapolis, Minnesota, 55454
About this study
Official title: Linking Primary Care, Communities and Families to Prevent Obesity Among Preschoolers
The goal of the Minnesota center is to integrate primary care, home, and community-based intervention strategies to promote sustained patterns of change in food intake, physical activity, and body weight among low income, ethnically diverse children. A culturally matched family connector will create linkages among the settings to support parents in making home environment and parenting behavior changes conducive to healthy growth and development in their children.
Specific Aim 1 To evaluate the effects of a three-year multi-setting parent-targeted randomized controlled intervention on the primary outcome, child BMI, compared to a standard primary care-only intervention among 500 low income ethnic minority two to four year old children who are at or above the 50th percentile of BMI for age and gender.
Read more
Hypothesis 1: Children in the multi-setting parent-targeted intervention will have a lower BMI at 24 and 36 months, compared with children in the standard primary care only control group.
Specific Aim 2 To evaluate the effects of a three-year multi-setting parent-targeted intervention on secondary outcomes, including change in child energy intake and physical activity energy expenditure, compared to a standard primary care-only intervention.
Hypothesis 2: Children in the multi-setting parent-targeted intervention will have lower energy intake and higher energy expenditure over the three-year period, compared with children in the standard primary care-only control group.
Specific Aim 3 To evaluate the effects of the multi-setting parent-targeted intervention on hypothesized mediators of change in dietary intake, physical activity, and BMI.
Hypothesis 3: It is hypothesized that changes in parenting behaviors and the home food and physical activity environment will mediate changes in child energy intake and expenditure, and body mass index (BMI).
Read the detailed description
- Trial design overview NET-Works is a two-arm, randomized controlled trial to test the efficacy of a multi-setting, multi-component intervention approach to preventing obesity among racially/ethnically diverse preschool age children. The NET-Works intervention includes four main components: 1) a pediatric primary care brief counseling intervention; 2) a home-based intervention delivered by NET-Works family connectors to support parents in making changes in the home environment and parenting practices to promote healthful eating and activity patterns; 3) community-based parenting classes designed to parallel the home-based intervention curriculum and provide social support to participating parents; and 4) linkages to neighborhood and community resources to support parents in promoting healthful eating and activity patterns for their children. Five hundred parent/child dyads were randomized to either the NET-Works intervention or a usual care comparison condition and followed for three years. Participants were assessed at baseline and annually. The primary hypothesis is that children randomized to the NET-Works intervention will have lower BMI (body mass index) at two and three years post-randomization relative to usual care comparison group children. BMI is the primary outcome across all four Childhood Obesity Prevention and Treatment Research (COPTR) trials. Recruitment for the trial began in July 2012 and was completed in December 2013, with the final three year follow-up data collected in December 2016.
- Study setting and population The target population for NET-Works was racially/ethnically diverse preschool children and their parent or primary caregiver. To reach the intended population, NET-Works partnered with 12 primary care clinics and three managed health care systems that serve diverse populations with respect to race, ethnicity and income. Over 18 months, 500 families were recruited, enrolled and randomized to the intervention or to the usual care comparison group. Administrative databases and centralized electronic scheduling systems at the partner clinics provided data needed to target recruitment efforts on two-to-four year old children residing in certain zip code areas. The clinics had data from preventive care visits available for calculation of child body mass index (BMI) percentile to focus recruitment efforts on children who were potentially BMI-eligible for the study.
- Recruitment Administrative databases and centralized electronic scheduling systems at three partner health care organizations provided data needed to target families of two-four year old children whose BMI percentile was at or above the 50th percentile for age and gender. Clinic liaisons obtained approval from each child's pediatrician to send a study invitation letter to the parent or primary caregiver. A list of physician-approved potentially eligible children was shared with the NET-Works recruitment team. NET-Works sent the parent or primary caregiver a study invitation letter from the pediatrician and researchers. Approximately five working days later, NET-Works recruitment staff followed up by phone to provide more information, ask additional screening questions, and assesses parent/primary caregiver's interest in the study. If the parent/primary caregiver was interested and the child appeared to be eligible, a home visit for eligibility confirmation, consent, and data collection was scheduled. The purpose of this initial home visit was to: 1) explain and discuss the study, and begin to develop rapport with parents; 2) measure the index child's height and weight to confirm eligibility; 3) obtain informed consent; and 4) begin the process of collecting baseline data. Based on our pilot study experience, we anticipated the majority of the participating parent/caregivers would be female and a significant number of Hispanic families as well as non-Hispanic White, African American, and multi-race participants would be recruited.
- Randomization Prior to the start of recruitment and enrollment, the study statistician created 6 blocked randomization schedules, one for each age group (2, 3, 4) by gender (M, F) stratum, that would equally allocated children to the NET-Works intervention or the usual care comparison group in blocks of 10 to ensure equivalent study group size. Parent-child dyads were randomized to treatment and control conditions after completion of all baseline measures, including data eligibility requirements established by the COPTR consortium. Data eligibility requirements included valid height and weight measurement, a minimum of one weekday and one weekend day NDS-R (nutritional data survey-revised) previous day dietary recall and four days of valid accelerometry data. The study coordinator randomly assigned the participant to the condition shown in the next available slot in the stratum-appropriate pre-defined randomization schedule. The investigators and all assessment staff remained blinded to experimental assignment until after the final follow-up assessments were completed.
- NET-Works intervention The NET-Works intervention was designed to reach into the home and family environment to influence parent behaviors and attitudes to support changes in the home that affect food availability, family meals, television viewing, and active play. Each intervention component would be situated in community settings where parents and children already live their lives. The intervention was expected to be effective in part through taking advantage of the settings that families already inhabit, and through coordination across settings to reinforce and link the messages, resources and feedback families receive about healthful food choices, physical activity, and body weight for their child. We believed the neighborhood-based model would be more likely to enhance class participation, reduce transportation needs/costs, allow the local community resources to be accessed more easily, and foster outside-of-class interpersonal connections among parents for enhanced social support. 5.1. Intervention components implementation overview The intervention curricula across each component (home visiting, parenting classes, neighborhood environment, pediatric primary care) was developed and refined during the pilot phase of the COPTR consortium. The intervention was designed to be implemented by trained research staff including a family connector who would conduct the home visiting and connector check-in calls and attend the parenting classes, and a parent educator who would conduct the community parenting classes that were based on the early childhood parenting class model and was developed in partnership with ECFE (early childhood and family education) in Minneapolis and St. Paul. The home visiting and parenting classes shared a common set of underlying curricula that included skills building around general parenting behaviors and the specific content behaviors targeted by the intervention (e.g., healthful snacks, family meals, physical activity). The family connector met parents and children in their own home, tailoring the intervention messages and strategies to best fit with the resources and motivations of parents. The family connector provided a one-on-one approach to synergize with the skills and strategies implemented in a group format in the NET-Works community parenting classes. Both home visiting and parenting classes directly connected parents to food and physical activity resources that already exist in their neighborhood ("community links"). Primary care providers bolstered these messages with parents during annual well-child visits. 5.2. Home visiting The goal of the home visiting was to help parents develop parenting skills, set goals related to child healthful eating, active play and reduced television viewing, and provided support for sustaining and building on these behavior and home environment changes. The dose for the home visiting intervention component was one visit per month for each of the three years. The family connector built a collaborative, partnership-based goal setting process for parents to facilitate child behavior change. Facilitation of the home visits was modeled on Motivational Interviewing, an approach designed to help individuals explore and resolve ambivalence about behavior change in a non-confrontational manner. Home visiting included a goal setting process guided by the family connector, healthful action activities to create norms and skills related to the targeted behaviors, and resources for links in the community to support healthful behaviors. Family connectors also checked in with participants to review progress on goals and provide support in between home visits. Family connector check-in contacts could be conducted over the telephone or via email. Family connectors had weekly supervision sessions with a licensed mental health provider with expertise in Motivational Interviewing to review progress with each participant, problem solve regarding any challenges that arise, and ensure adherence to the intervention protocol. 5.3. Parenting classes The parenting classes were designed to work synergistically with the home visiting curriculum. The parenting class and the home visiting curriculum both included topics that addressed parenting skills development, the home food environment, healthful eating, family meals, television viewing limits, active play, and goal setting. The parenting class provided a group format where parents could share their experiences, gain support from other parents and learn from each other. The curriculum was research-based and facilitated by a trained parent educator. The dose for the parenting class component was 12 classes per year for each of the three years. The curriculum in years 2 and 3 built upon and deepen the topics introduced in year 1, and addressed parenting and developmental issues as children progress from ages 2-7 years of age. Parent educators also participated in weekly supervision sessions to ensure adherence to the intervention protocol. 5.4. Neighborhood and community initiative The purpose of the neighborhood and community intervention component was to increase access to, and use of, healthful food, physical activity, and school readiness resources available in the neighborhood communities where study participants live. Parents were directly linked with resources in their neighborhood through both the parenting classes and the family connector home visits. Community initiatives implemented with the family connector included conducting a walkability assessment of the family's neighborhood. The family connector reviewed neighborhood food and physical activity resources with the parent at each home visit, and encouraged them to use these resources to support their home and behavior changes. The community links included one school readiness community activity (e.g., a library visit) to promote developmental parenting, sustain parent interest, and provide active support for whole child development. Four community links were included in the parenting class and home visiting curriculum each year of the intervention. 5.5. Primary care The primary care provider is an influential connection for parents. In NET-Works, the primary care provider delivered key messages around parent behaviors for shaping, reinforcing and sustaining healthful child eating and physical activity behaviors and body weight. To support providers in delivering key messages to parents during well child visits, a brochure was developed in partnership with the participating clinic systems. The brochure was used by the primary care provider to converse about child BMI percentile and strategies parents could use to promote their child's healthful eating and activity patterns. The NET-Works family connector will also provided information about progress on intervention goals to the primary care provider on an annual basis to reinforce continuity and integration of intervention messages. The primary care intervention linked with the community parenting classes and home visiting to deliver consistent intervention messages over a sustained time period.
- Intervention component integration Linkages across the intervention components were created in several ways with the family connector playing a key role in this connectivity. Specifically, in addition to conducting home visits, family connectors facilitated participant entry into parenting classes and also attended parenting classes. Attending parenting classes allowed the family connector to be knowledgeable about the parenting class content and the experience their assigned participants were having during class. This information informed the goal setting that family connectors and parents worked on during home visits. Family connectors also served as the liaison between parents and primary care providers. The home visits and parenting classes also incorporated connections to community resources for physical activity and healthy eating as described above.
- Usual care comparison group The usual care comparison group received the primary care provider component described above, and quarterly newsletters with information about their child's general health and wellness and school readiness.
- Participant timeline, assessments, and measures Data collection took place in the home setting at baseline, 12, 24, and 36 months by trained and certified, bilingual English and Spanish research specialists, blinded to experimental assignment. At 6, 18, and 30 months, a brief telephone survey was conducted. Participants receive a total of $50 in gift cards for each set of measurement visits (baseline and each subsequent annual assessment) and a $5 gift card for each brief telephone survey. Data collectors were trained by the investigators and, for COPTR consortium common measures, by the Research Coordinating Unit (RCU) according to standardized protocols. COPTR used a train-the-trainer model. "Master Trainers" who participated in a central training organized by the RCU were responsible for training and certifying the data collection staff at their field center. Data collectors were required to demonstrate high inter- and intra-rater reliability prior to data collection.
- Statistical analyses The primary efficacy analysis was designed to test whether two to four year old children who were randomized to the NET-Works program have statistically and clinically lower BMI at 24 and 36 months post randomization relative to usual care comparison group children with age at randomization (2, 3, 4), sex (F, M) and BMI at baseline used as covariates. According to the study protocol, all covariates in the primary analysis would be measured at baseline prior to randomization and therefore available for observed and unobserved BMI values.
- Data monitoring and participant safety The data safety and monitoring plan included assessing adverse events systematically at each data collection visit with direct queries for all injuries, illnesses or other medical problems requiring a visit to a medical care provider and related to participation in the study. Serious Adverse Events (SAEs) were specifically monitored. Adverse events were also be recorded and evaluated when they came to the attention of study staff between the data collection visits. An independent Data and Safety Monitoring Board was selected to review study protocols and provide oversight of recruitment and study progress, data quality and completeness, and participant safety.
- Conditions
- Childhood Obesity
- Being tested
- multi-component/setting parent-targeted intervention
- Keywords
- preschooler obesity prevention, community home visiting parents, preschooler excess BMI gain, multi-setting/component intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-component/setting parent-targeted interventionBehavioural
parents assigned to this group will be asked to participate in a program of home visiting, community parenting classes, and community food and physical activity resource links
| Study group | Role | What they receive |
|---|---|---|
| parent-targeted intervention | Experimental | experimental Receives: Behavioral: multi-component/setting parent-targeted intervention |
| Primary Care | No intervention | Standard primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index
Measured: three years
Secondary outcomes (1)
energy intake
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2012 (estimated)
- Study startJun 2012
- Primary completion21 Mar 2017
- Study completion21 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone A French, PhD, Principal investigator, University of MinnesotaNancy E Sherwood, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606891
- Sponsor's protocol ID
- U01HD068990
- Acronym
- NET-Works
- Status last verified
- Oct 2018
- First submitted
- 23 May 2012
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jang S, Goodman L, Sherwood NE, French SA, Kunin-Batson A, de Brito JN. Early-Life Sociodemographic Factors and Cardiovascular Health in Preadolescence Among Low-Income and Racially and Ethnically Diverse Children. J Am Heart Assoc. 2025 Nov 4;14(21):e040692. doi: 10.1161/JAHA.124.040692. Epub 2025 Oct 23.
PubMed 41128142JaKa MM, Wood C, Veblen-Mortenson S, Moore SM, Matheson D, Stevens J, Atkins L, Michie S, Adegbite-Adeniyi C, Olayinka O, Po'e EK, Kelly AM, Nicastro H, Bangdiwala SI, Barkin SL, Pratt C, Robinson TN, Sherwood NE. Applying the Behavior Change Technique Taxonomy to Four Multicomponent Childhood Obesity Interventions. West J Nurs Res. 2021 May;43(5):468-477. doi: 10.1177/0193945920954782. Epub 2020 Sep 10.
PubMed 32909523Berge JM, Miller J, Veblen-Mortenson S, Kunin-Batson A, Sherwood NE, French SA. A Bidirectional Analysis of Feeding Practices and Eating Behaviors in Parent/Child Dyads from Low-Income and Minority Households. J Pediatr. 2020 Jun;221:93-98.e20. doi: 10.1016/j.jpeds.2020.02.001. Epub 2020 Apr 1.
PubMed 32247517Cui Z, Truesdale KP, Robinson TN, Pemberton V, French SA, Escarfuller J, Casey TL, Hotop AM, Matheson D, Pratt CA, Lotas LJ, Po'e E, Andrisin S, Ward DS. Recruitment strategies for predominantly low-income, multi-racial/ethnic children and parents to 3-year community-based intervention trials: Childhood Obesity Prevention and Treatment Research (COPTR) Consortium. Trials. 2019 May 28;20(1):296. doi: 10.1186/s13063-019-3418-0.
PubMed 31138278French SA, Sherwood NE, Veblen-Mortenson S, Crain AL, JaKa MM, Mitchell NR, Hotop AM, Berge JM, Kunin Batson AS, Truesdale K, Stevens J, Pratt C, Esposito L. Multicomponent Obesity Prevention Intervention in Low-Income Preschoolers: Primary and Subgroup Analyses of the NET-Works Randomized Clinical Trial, 2012-2017. Am J Public Health. 2018 Dec;108(12):1695-1706. doi: 10.2105/AJPH.2018.304696.
PubMed 30403521Ruiz RM, Sommer EC, Tracy D, Banda JA, Economos CD, JaKa MM, Evenson KR, Buchowski MS, Barkin SL. Novel patterns of physical activity in a large sample of preschool-aged children. BMC Public Health. 2018 Feb 13;18(1):242. doi: 10.1186/s12889-018-5135-0.
PubMed 29439704Sherwood NE, French SA, Veblen-Mortenson S, Crain AL, Berge J, Kunin-Batson A, Mitchell N, Senso M. NET-Works: Linking families, communities and primary care to prevent obesity in preschool-age children. Contemp Clin Trials. 2013 Nov;36(2):544-54. doi: 10.1016/j.cct.2013.09.015. Epub 2013 Oct 9.
PubMed 24120933
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Primary Care, Communities and Families to Prevent Obesity Among Preschoolers
- ClinicalTrials.gov ID
- NCT01606891
- Acronym / sponsor ID
- NET-Works / U01HD068990
- Conditions
- Childhood Obesity
- Keywords
- preschooler obesity prevention, community home visiting parents, preschooler excess BMI gain, multi-setting/component intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- 21 Mar 2017 (actual)
- Study completion
- 21 Mar 2017 (actual)
- First posted
- 28 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the Minnesota center is to integrate primary care, home, and community-based intervention strategies to promote sustained patterns of change in food intake, physical activity, and body weight among low income, ethnically diverse children. A culturally matched family connector will create linkages among the settings to support parents in making home environment and parenting behavior changes conducive to healthy growth and development in their children.
Specific Aim 1 To evaluate the effects of a three-year multi-setting parent-targeted randomized controlled intervention on the primary outcome, child BMI, compared to a standard primary care-only intervention among 500 low income ethnic minority two to four year old children who are at or above the 50th percentile of BMI for age and gender.
Hypothesis 1: Children in the multi-setting parent-targeted intervention will have a lower BMI at 24 and 36 months, compared with children in the standard primary care only control group.
Specific Aim 2 To evaluate the effects of a three-year multi-setting parent-targeted intervention on secondary outcomes, including change in child energy intake and physical activity energy expenditure, compared to a standard primary care-only intervention.
Hypothesis 2: Children in the multi-setting parent-targeted intervention will have lower energy intake and higher energy expenditure over the three-year period, compared with children in the standard primary care-only control group.
Specific Aim 3 To evaluate the effects of the multi-setting parent-targeted intervention on hypothesized mediators of change in dietary intake, physical activity, and BMI.
Hypothesis 3: It is hypothesized that changes in parenting behaviors and the home food and physical activity environment will mediate changes in child energy intake and expenditure, and body mass index (BMI).
Detailed description
- Trial design overview NET-Works is a two-arm, randomized controlled trial to test the efficacy of a multi-setting, multi-component intervention approach to preventing obesity among racially/ethnically diverse preschool age children. The NET-Works intervention includes four main components: 1) a pediatric primary care brief counseling intervention; 2) a home-based intervention delivered by NET-Works family connectors to support parents in making changes in the home environment and parenting practices to promote healthful eating and activity patterns; 3) community-based parenting classes designed to parallel the home-based intervention curriculum and provide social support to participating parents; and 4) linkages to neighborhood and community resources to support parents in promoting healthful eating and activity patterns for their children. Five hundred parent/child dyads were randomized to either the NET-Works intervention or a usual care comparison condition and followed for three years. Participants were assessed at baseline and annually. The primary hypothesis is that children randomized to the NET-Works intervention will have lower BMI (body mass index) at two and three years post-randomization relative to usual care comparison group children. BMI is the primary outcome across all four Childhood Obesity Prevention and Treatment Research (COPTR) trials. Recruitment for the trial began in July 2012 and was completed in December 2013, with the final three year follow-up data collected in December 2016.
- Study setting and population The target population for NET-Works was racially/ethnically diverse preschool children and their parent or primary caregiver. To reach the intended population, NET-Works partnered with 12 primary care clinics and three managed health care systems that serve diverse populations with respect to race, ethnicity and income. Over 18 months, 500 families were recruited, enrolled and randomized to the intervention or to the usual care comparison group. Administrative databases and centralized electronic scheduling systems at the partner clinics provided data needed to target recruitment efforts on two-to-four year old children residing in certain zip code areas. The clinics had data from preventive care visits available for calculation of child body mass index (BMI) percentile to focus recruitment efforts on children who were potentially BMI-eligible for the study.
- Recruitment Administrative databases and centralized electronic scheduling systems at three partner health care organizations provided data needed to target families of two-four year old children whose BMI percentile was at or above the 50th percentile for age and gender. Clinic liaisons obtained approval from each child's pediatrician to send a study invitation letter to the parent or primary caregiver. A list of physician-approved potentially eligible children was shared with the NET-Works recruitment team. NET-Works sent the parent or primary caregiver a study invitation letter from the pediatrician and researchers. Approximately five working days later, NET-Works recruitment staff followed up by phone to provide more information, ask additional screening questions, and assesses parent/primary caregiver's interest in the study. If the parent/primary caregiver was interested and the child appeared to be eligible, a home visit for eligibility confirmation, consent, and data collection was scheduled. The purpose of this initial home visit was to: 1) explain and discuss the study, and begin to develop rapport with parents; 2) measure the index child's height and weight to confirm eligibility; 3) obtain informed consent; and 4) begin the process of collecting baseline data. Based on our pilot study experience, we anticipated the majority of the participating parent/caregivers would be female and a significant number of Hispanic families as well as non-Hispanic White, African American, and multi-race participants would be recruited.
- Randomization Prior to the start of recruitment and enrollment, the study statistician created 6 blocked randomization schedules, one for each age group (2, 3, 4) by gender (M, F) stratum, that would equally allocated children to the NET-Works intervention or the usual care comparison group in blocks of 10 to ensure equivalent study group size. Parent-child dyads were randomized to treatment and control conditions after completion of all baseline measures, including data eligibility requirements established by the COPTR consortium. Data eligibility requirements included valid height and weight measurement, a minimum of one weekday and one weekend day NDS-R (nutritional data survey-revised) previous day dietary recall and four days of valid accelerometry data. The study coordinator randomly assigned the participant to the condition shown in the next available slot in the stratum-appropriate pre-defined randomization schedule. The investigators and all assessment staff remained blinded to experimental assignment until after the final follow-up assessments were completed.
- NET-Works intervention The NET-Works intervention was designed to reach into the home and family environment to influence parent behaviors and attitudes to support changes in the home that affect food availability, family meals, television viewing, and active play. Each intervention component would be situated in community settings where parents and children already live their lives. The intervention was expected to be effective in part through taking advantage of the settings that families already inhabit, and through coordination across settings to reinforce and link the messages, resources and feedback families receive about healthful food choices, physical activity, and body weight for their child. We believed the neighborhood-based model would be more likely to enhance class participation, reduce transportation needs/costs, allow the local community resources to be accessed more easily, and foster outside-of-class interpersonal connections among parents for enhanced social support. 5.1. Intervention components implementation overview The intervention curricula across each component (home visiting, parenting classes, neighborhood environment, pediatric primary care) was developed and refined during the pilot phase of the COPTR consortium. The intervention was designed to be implemented by trained research staff including a family connector who would conduct the home visiting and connector check-in calls and attend the parenting classes, and a parent educator who would conduct the community parenting classes that were based on the early childhood parenting class model and was developed in partnership with ECFE (early childhood and family education) in Minneapolis and St. Paul. The home visiting and parenting classes shared a common set of underlying curricula that included skills building around general parenting behaviors and the specific content behaviors targeted by the intervention (e.g., healthful snacks, family meals, physical activity). The family connector met parents and children in their own home, tailoring the intervention messages and strategies to best fit with the resources and motivations of parents. The family connector provided a one-on-one approach to synergize with the skills and strategies implemented in a group format in the NET-Works community parenting classes. Both home visiting and parenting classes directly connected parents to food and physical activity resources that already exist in their neighborhood ("community links"). Primary care providers bolstered these messages with parents during annual well-child visits. 5.2. Home visiting The goal of the home visiting was to help parents develop parenting skills, set goals related to child healthful eating, active play and reduced television viewing, and provided support for sustaining and building on these behavior and home environment changes. The dose for the home visiting intervention component was one visit per month for each of the three years. The family connector built a collaborative, partnership-based goal setting process for parents to facilitate child behavior change. Facilitation of the home visits was modeled on Motivational Interviewing, an approach designed to help individuals explore and resolve ambivalence about behavior change in a non-confrontational manner. Home visiting included a goal setting process guided by the family connector, healthful action activities to create norms and skills related to the targeted behaviors, and resources for links in the community to support healthful behaviors. Family connectors also checked in with participants to review progress on goals and provide support in between home visits. Family connector check-in contacts could be conducted over the telephone or via email. Family connectors had weekly supervision sessions with a licensed mental health provider with expertise in Motivational Interviewing to review progress with each participant, problem solve regarding any challenges that arise, and ensure adherence to the intervention protocol. 5.3. Parenting classes The parenting classes were designed to work synergistically with the home visiting curriculum. The parenting class and the home visiting curriculum both included topics that addressed parenting skills development, the home food environment, healthful eating, family meals, television viewing limits, active play, and goal setting. The parenting class provided a group format where parents could share their experiences, gain support from other parents and learn from each other. The curriculum was research-based and facilitated by a trained parent educator. The dose for the parenting class component was 12 classes per year for each of the three years. The curriculum in years 2 and 3 built upon and deepen the topics introduced in year 1, and addressed parenting and developmental issues as children progress from ages 2-7 years of age. Parent educators also participated in weekly supervision sessions to ensure adherence to the intervention protocol. 5.4. Neighborhood and community initiative The purpose of the neighborhood and community intervention component was to increase access to, and use of, healthful food, physical activity, and school readiness resources available in the neighborhood communities where study participants live. Parents were directly linked with resources in their neighborhood through both the parenting classes and the family connector home visits. Community initiatives implemented with the family connector included conducting a walkability assessment of the family's neighborhood. The family connector reviewed neighborhood food and physical activity resources with the parent at each home visit, and encouraged them to use these resources to support their home and behavior changes. The community links included one school readiness community activity (e.g., a library visit) to promote developmental parenting, sustain parent interest, and provide active support for whole child development. Four community links were included in the parenting class and home visiting curriculum each year of the intervention. 5.5. Primary care The primary care provider is an influential connection for parents. In NET-Works, the primary care provider delivered key messages around parent behaviors for shaping, reinforcing and sustaining healthful child eating and physical activity behaviors and body weight. To support providers in delivering key messages to parents during well child visits, a brochure was developed in partnership with the participating clinic systems. The brochure was used by the primary care provider to converse about child BMI percentile and strategies parents could use to promote their child's healthful eating and activity patterns. The NET-Works family connector will also provided information about progress on intervention goals to the primary care provider on an annual basis to reinforce continuity and integration of intervention messages. The primary care intervention linked with the community parenting classes and home visiting to deliver consistent intervention messages over a sustained time period.
- Intervention component integration Linkages across the intervention components were created in several ways with the family connector playing a key role in this connectivity. Specifically, in addition to conducting home visits, family connectors facilitated participant entry into parenting classes and also attended parenting classes. Attending parenting classes allowed the family connector to be knowledgeable about the parenting class content and the experience their assigned participants were having during class. This information informed the goal setting that family connectors and parents worked on during home visits. Family connectors also served as the liaison between parents and primary care providers. The home visits and parenting classes also incorporated connections to community resources for physical activity and healthy eating as described above.
- Usual care comparison group The usual care comparison group received the primary care provider component described above, and quarterly newsletters with information about their child's general health and wellness and school readiness.
- Participant timeline, assessments, and measures Data collection took place in the home setting at baseline, 12, 24, and 36 months by trained and certified, bilingual English and Spanish research specialists, blinded to experimental assignment. At 6, 18, and 30 months, a brief telephone survey was conducted. Participants receive a total of $50 in gift cards for each set of measurement visits (baseline and each subsequent annual assessment) and a $5 gift card for each brief telephone survey. Data collectors were trained by the investigators and, for COPTR consortium common measures, by the Research Coordinating Unit (RCU) according to standardized protocols. COPTR used a train-the-trainer model. "Master Trainers" who participated in a central training organized by the RCU were responsible for training and certifying the data collection staff at their field center. Data collectors were required to demonstrate high inter- and intra-rater reliability prior to data collection.
- Statistical analyses The primary efficacy analysis was designed to test whether two to four year old children who were randomized to the NET-Works program have statistically and clinically lower BMI at 24 and 36 months post randomization relative to usual care comparison group children with age at randomization (2, 3, 4), sex (F, M) and BMI at baseline used as covariates. According to the study protocol, all covariates in the primary analysis would be measured at baseline prior to randomization and therefore available for observed and unobserved BMI values.
- Data monitoring and participant safety The data safety and monitoring plan included assessing adverse events systematically at each data collection visit with direct queries for all injuries, illnesses or other medical problems requiring a visit to a medical care provider and related to participation in the study. Serious Adverse Events (SAEs) were specifically monitored. Adverse events were also be recorded and evaluated when they came to the attention of study staff between the data collection visits. An independent Data and Safety Monitoring Board was selected to review study protocols and provide oversight of recruitment and study progress, data quality and completeness, and participant safety.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| parent-targeted intervention | Experimental | Behavioral: multi-component/setting parent-targeted interventionexperimental |
| Primary Care | No intervention | –Standard primary care |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- A child and his or her parent(s) will be eligible for the study if:
Key exclusion criteria (1 listed)
- A child will be excluded if she or he does not meet the above eligibility criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multi-component/setting parent-targeted interventionparents assigned to this group will be asked to participate in a program of home visiting, community parenting classes, and community food and physical activity resource links | Behavioural | parent-targeted intervention |
Primary outcome
body mass index
Time frame: three years
1 secondary outcome
energy intake
Time frame: three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Derived from this study: PubMed 41128142Jang S, Goodman L, Sherwood NE, French SA, Kunin-Batson A, de Brito JN. Early-Life Sociodemographic Factors and Cardiovascular Health in Preadolescence Among Low-Income and Racially and Ethnically Diverse Children. J Am Heart Assoc. 2025 Nov 4;14(21):e040692. doi: 10.1161/JAHA.124.040692. Epub 2025 Oct 23.
- Derived from this study: PubMed 32909523JaKa MM, Wood C, Veblen-Mortenson S, Moore SM, Matheson D, Stevens J, Atkins L, Michie S, Adegbite-Adeniyi C, Olayinka O, Po'e EK, Kelly AM, Nicastro H, Bangdiwala SI, Barkin SL, Pratt C, Robinson TN, Sherwood NE. Applying the Behavior Change Technique Taxonomy to Four Multicomponent Childhood Obesity Interventions. West J Nurs Res. 2021 May;43(5):468-477. doi: 10.1177/0193945920954782. Epub 2020 Sep 10.
- Derived from this study: PubMed 32247517Berge JM, Miller J, Veblen-Mortenson S, Kunin-Batson A, Sherwood NE, French SA. A Bidirectional Analysis of Feeding Practices and Eating Behaviors in Parent/Child Dyads from Low-Income and Minority Households. J Pediatr. 2020 Jun;221:93-98.e20. doi: 10.1016/j.jpeds.2020.02.001. Epub 2020 Apr 1.
- Derived from this study: PubMed 31138278Cui Z, Truesdale KP, Robinson TN, Pemberton V, French SA, Escarfuller J, Casey TL, Hotop AM, Matheson D, Pratt CA, Lotas LJ, Po'e E, Andrisin S, Ward DS. Recruitment strategies for predominantly low-income, multi-racial/ethnic children and parents to 3-year community-based intervention trials: Childhood Obesity Prevention and Treatment Research (COPTR) Consortium. Trials. 2019 May 28;20(1):296. doi: 10.1186/s13063-019-3418-0.
- Derived from this study: PubMed 30403521French SA, Sherwood NE, Veblen-Mortenson S, Crain AL, JaKa MM, Mitchell NR, Hotop AM, Berge JM, Kunin Batson AS, Truesdale K, Stevens J, Pratt C, Esposito L. Multicomponent Obesity Prevention Intervention in Low-Income Preschoolers: Primary and Subgroup Analyses of the NET-Works Randomized Clinical Trial, 2012-2017. Am J Public Health. 2018 Dec;108(12):1695-1706. doi: 10.2105/AJPH.2018.304696.
- Derived from this study: PubMed 29439704Ruiz RM, Sommer EC, Tracy D, Banda JA, Economos CD, JaKa MM, Evenson KR, Buchowski MS, Barkin SL. Novel patterns of physical activity in a large sample of preschool-aged children. BMC Public Health. 2018 Feb 13;18(1):242. doi: 10.1186/s12889-018-5135-0.
- Derived from this study: PubMed 24120933Sherwood NE, French SA, Veblen-Mortenson S, Crain AL, Berge J, Kunin-Batson A, Mitchell N, Senso M. NET-Works: Linking families, communities and primary care to prevent obesity in preschool-age children. Contemp Clin Trials. 2013 Nov;36(2):544-54. doi: 10.1016/j.cct.2013.09.015. Epub 2013 Oct 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone A French, PhD principal investigator
University of Minnesota
Nancy E Sherwood, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-component/setting parent-targeted intervention in people with Childhood Obesity, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body mass index (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01606891, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.