ObesityHCSF2NCT01776255
Healthy Children, Strong Families: American Indian Communities Preventing Obesity
A study testing Healthy Children, Strong Families and Child Safety in people with Obesity and Overweight, run by University of Wisconsin, Madison at 5 sites in United States.
Trial summary
Healthy Children, Strong Families-2 (HCSF-2) is a family focused early childhood intervention which addresses the growing problem of childhood obesity in American Indian communities. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Healthy Children, Strong Families and Child Safety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2013to 27 Apr 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adult caregiver with a 2-5 year old child
- 2-5 year old child with a caregiver
- Caregiver has a working cell phone and is willing to receive regular text messages as part of study participation
- Caregiver lives within feasible travel distance of data collection site and willing to come for data collection visits at 0, 6 months, 12 months, 18 months and 24 months
- Willingness to be randomized to one of two groups with the understanding that all participants will receive all components of the intervention, randomization simply determines the order in which materials are received
- Valid mailing address where participant can receive mail and packages
- Basic English fluency and literacy sufficient for understanding the intervention materials and completing questionnaires
Who cannot join
- Adults with no children or whose only children are younger than 2 or older than 5
- Children younger than 2 or older than 5 years of age
- No cell phone or unwilling to receive regular text messages as part of study participation
- Lives beyond feasible travel distance of data collection sites AND/OR planning on moving out of the area within a two year period
- Child has major physical or behavioral disorder (e.g. failure to thrive, severe autism) that would seriously impact study participation
- No valid mailing address
- Unwillingness to accept random allocation to study arm
- Spouse/partner of another caregiver-child pair who is living in same home \& who has already enrolled (e.g. only one adult-child pair per household may be enrolled)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
First Nations HealthSource
Albuquerque, New Mexico, 87108
Blackfeet Nation
Browning, Montana, 59417
Seneca Nation
Irving, New York, 14081
Menominee Tribe of Wisconsin
Keshena, Wisconsin, 54135
White Earth Child Care Program
White Earth, Minnesota, 56591
About this study
Healthy Children, Strong Families-2 (HCSF-2) is a family focused early childhood intervention which addresses the growing problem of childhood obesity in American Indian communities. The study works with six rural and urban American Indian communities across the US to test the ability of the intervention to increase adoption of healthy lifestyles and to reduce the prevalence of obesity among preschool aged American Indian children and their primary caregivers - creating healthier children, healthier families and healthier communities. Our primary hypothesis is that children and their primary caregivers who receive the HCSF-2 intervention will have better obesity related outcomes than those who do not receive HCSF-2.
Read the detailed description
Intervention
The Healthy Children, Strong Families-2 (HCSF-2) intervention consists of monthly mailed healthy lifestyle lessons (13 lessons) which will be dose enhanced with social networking support (cell-phone coaching with instant text messages and Facebook connections), as well as new intervention elements-stress and sleep. Social networking was chosen due to its widespread and ease of use, adaptability and potential for sustainability in the community.
HCSF-2 is based on our hypothesis that working with children and their primary caregivers/parent to assist them in making healthy lifestyle changes is necessary to prevent excessive weight gain and risk of later lifestyle related chronic disease. Investigators will work with families at a critical time in their young child's physical and emotional development to encourage appropriate healthy lifestyle behaviors.
This study will expand on our previous research to test the HCSF-2 intervention in a larger, more geographically and socially diverse sample of AI communities. The study also enhances the prior methodology through the inclusion of a social networking component. This research will address four key gaps in obesity prevention studies: families with preschool age children, social networking support, stress and sleep. Moreover, to our knowledge, this study will be the first family-based obesity intervention project for both rural and urban AI families. The potential impact of this study is high; if successful, this study will not only provide quantitative evidence of the effectiveness of the intervention but it will also give other investigators validated tools and procedures to collaboratively engage AI communities in health behavior change.
Year 1, families will be randomized to start in the HCSF-2 intervention or an active control (mailed child safety newsletters). Then, in Year 2, intervention change will occur, such that HCSF-2 intervention families will receive the control safety lessons plus continued HCSF-2 social networking, while control families will now receive the full HCSF-2 intervention.
For example, families will be randomly assigned to begin in one of the two arms - denoted here as the HCSF-2 intervention (Phase A) or Child Safety intervention (Phase B).
During the HCSF-2 intervention (Phase A) families will receive a monthly mailing with information about nutrition and physical activity, screen time, sleep and stress management. Families will also be invited to participate in a private Facebook group and will begin receiving wellness coaching text messages from the study.
During the Child Safety intervention (Phase B) families will receive a monthly mailing with information about safety topics such as car safety, water safety, poisoning and home safety.
After one year, families will flip into the second phase until the two year study period is complete. Families who began in Phase A will continue to receive wellness coaching text messages and have access to the private Facebook group. Families who began in Phase B will not receive wellness coaching text messages or have access to the private Facebook group until the flip into Phase A at the start of year two.
This staggered enrollment design, chosen in conjunction with the participating communities, maximizes the contribution of each participating family, avoids the negative attitudes that would occur with a wait-list only control and ensures all families receive the intervention as desired by the participating tribal sites.
This is a multi-site trial with up to six possible participating communities. Two sites will become active at the beginning of the intervention with remaining sites becoming active (and being added to the IRB protocol) at roughly 1 year intervals.
A local site coordinator will be hired at each participating site. The local site coordinator will be responsible for recruiting participants, and conducting data collection visits. Site coordinators may also send wellness coaching text messages and post content to the private Facebook group.
The UW program coordinator will be responsible for screening participants for eligibility, administering 24-hour dietary recalls by phone, mailing HCSF-2 curriculum materials and Child Safety materials, managing the entry and storage of study data, sending results letters to participants and supporting the community site coordinators.
Methods
Investigators will partner with 6 diverse rural and urban AI communities nationally to conduct a 2-arm staggered-enrollment randomized trial of an enhanced version of the HCSF intervention (HCSF-2) vs. active control (Child Safety intervention) in a 2-year design with outcomes measured at 0, 6, 12, 18 and 24 months. At the end of year 1, control families will receive HCSF-2, and HCSF-2 families will receive the control intervention with continued HCSF-2 social network support. Communities will work with us to enhance the family-focused HCSF-2 intervention to include novel methods of delivery (mailed lessons with social networking/cell phone text coaching) and two less-studied obesity determinants-sleep and stress-to increase impact and sustainability.
Outcomes
Primary outcomes will be body fat as assessed by child Body Mass Index z-score (zBMI) and adult Body Mass Index (BMI). Secondary outcomes include adult and child waist circumference, fruit/vegetable (FV) and added sugar intake, TV/screen time, activity, sleep, home environment changes, adult psychosocial factors (stress/depression) and social network use.
Investigators will also identify key mediators of the effect of HCSF-2 on obesity and health behaviors. We hypothesize that modifiable behavior changes in children and caregivers, adult self-efficacy, social support and home environment changes are important mediators of the effect of the intervention on obesity and other outcomes. Investigators will develop and test exploratory mixed-effects regression models to investigate mediation on the path from HCSF-2 to weight reduction.
- Conditions
- Obesity, Overweight
- Being tested
- Healthy Children, Strong Families, Child Safety
- Keywords
- Obesity, Overweight, Lifestyle, American Indian
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Children, Strong FamiliesBehavioural
Healthy Children, Strong Families is a series of 13 "lessons" mailed to primary caregivers of preschool aged children that provide education and activities related to obesity prevention. The lessons cover topics related to nutrition, physical activity, stress, sleep, and the home environment. Lessons include printed materials and small items (for example, an apple sectioner) that support activities in the lessons. Social support components via a monitored Facebook group and approximately semiweekly text messages sent to caregivers are included. The intervention spans 1 year.
Child SafetyBehavioural
The Child Safety intervention is an active control condition consisting of monthly two-page newsletters covering various topics relevant to child safety such as choking, car safety seats, bike and pedestrian safety. The intervention spans 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Children, Strong Families (first) | Experimental | Healthy Children, Strong Families intervention (first). This is a series of monthly educational tool kits mailed to primary caregivers for use with the participating child. This arm crosses over to receive the Child Safety in Year 2. Receives: Behavioral: Healthy Children, Strong Families; Behavioral: Child Safety |
| Child Safety (first) | Active comparator | A series of 12 monthly newsletters and providing education on child safety mailed to primary caregivers. This Arm crosses over to receive the Healthy Children, Strong Families intervention in Year 2. Receives: Behavioral: Healthy Children, Strong Families; Behavioral: Child Safety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child adiposity from baseline measured via BMI z-score
BMI z-score is obtained by computing the BMI weight (in kg)/height (in m)*height (in m). BMI is then converted to a z-score based on US national norms for gender and age in months provided
Measured: Enrollment, 6 months, 12 months, 18 months, 24 months
Change in adult adiposity from baseline measured via BMI
Adult BMI is computed from weight (in kg) divided by height (in m) squared
Measured: Enrollment, 12 months, 24 months
Secondary outcomes (14)
Change in child adiposity from baseline measured via waist circumference
Waist circumference (in cm) is measured with a plastic measuring tape
Measured: Enrollment, 6 months, 12 months, 18 months, 24 months
Change in adult adiposity from baseline measured via waist circumference
Waist circumference (in cm) is measured with a plastic measuring tape
Measured: Enrollment, 12 months, 24 months
Change in child fruit and vegetable consumption from baseline
Child fruit and vegetable consumption measured via a 13-item questionnaire completed by the primary caregiver that is based on questions contained in the 2010 National Youth Physical Activity and Nutrition Survey published by the Centers for Disease Control and Prevention
Measured: Enrollment, 12 months, 24 months
Change in adult fruit and vegetable consumption from basline
Adult fruit and vegetable consumption is measured with a 30-item questionnaire published by the National Cancer Institute.
Measured: Enrollment, 12 months, 24 months
Change in amount of child screen time from basline
Amount of time spent watching TV, videos, video games, and computer are assessed via 8 items on a questionnaire completed by primary caregiver.
Measured: Enrollment, 12 month, 24 month
Change in amount of adult screen time from basline
Amount of time spent watching TV, videos, video games, and computer are assessed via 8 items on a questionnaire.
Measured: Enrollment, 12 month, 24 month
Change in amount of child physical activity from baseline
Child physical activity is measured via primary caregiver's responses to the 8 items on the Netherlands Physical Activity Questionnaire.
Measured: Enrollment, 12 months, 24 months
Change in amount of adult physical activity from basline
Adult physical activity is measured via the 4 item Godin physical activity questionnaire.
Measured: Enrollment, 12 months, 24 months
Change in child sleep pattern from basline
Primary caregivers complete a 6-question sleep questionnaire on sleep timing (weekday and weekend bedtime and awakening)and sleep duration in hours as well as sleep latency for both themselves and the participating child.
Measured: Enrollment, 12 months, 24 months
Change in home environment from basline
Primary caregivers complete a 24 item questionnaire pertaining to the availability of supports and family routines relevant to physical activity and nutrition.
Measured: Enrollment, 12 months, 24 months
Change in adult Readiness to Change from basline
Primary caregivers complete a 7 item questionnaire pertaining to readiness to change behaviors relevant to obesity.
Measured: Enrollment, 6 months, 12 months, 18 months, 24 months
Change in adult SF-12 scores from basline
Primary caregivers complete a 12-item questionnaire that poses questions about their perception of their physical and emotional well being.
Measured: Enrollment, 12 months, 24 months
Stress questionnaire
Primary caregivers complete a 10-item questionnaire pertaining to perceptions of global areas of stress.
Measured: Enrollment, 12 months, 24 months
Change in adult sleep pattern from basline
Primary caregivers complete a 6-question sleep questionnaire on sleep timing (weekday and weekend bedtime and awakening)and sleep duration in hours as well as sleep latency for both themselves and the participating child.
Measured: Enrollment, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startJan 2013
- Primary completion27 Apr 2017
- Study completion27 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Alexandra K Adams, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776255
- Sponsor's protocol ID
- 2012-0578
- Other IDs
- 1R01HL114912-01
- Acronym
- HCSF2
- Status last verified
- Oct 2017
- First submitted
- 16 Jan 2013
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Adams AK, LaRowe TL, Cronin KA, Prince RJ, Wubben DP, Parker T, Jobe JB. The Healthy Children, Strong Families intervention: design and community participation. J Prim Prev. 2012 Aug;33(4):175-85. doi: 10.1007/s10935-012-0275-y.
PubMed 22956296Jobe JB, Adams AK, Henderson JA, Karanja N, Lee ET, Walters KL. Community-responsive interventions to reduce cardiovascular risk in American Indians. J Prim Prev. 2012 Aug;33(4):153-9. doi: 10.1007/s10935-012-0277-9.
PubMed 22983753LaRowe TL, Wubben DP, Cronin KA, Vannatter SM, Adams AK. Development of a culturally appropriate, home-based nutrition and physical activity curriculum for Wisconsin American Indian families. Prev Chronic Dis. 2007 Oct;4(4):A109. Epub 2007 Sep 15.
PubMed 17875253Tomayko EJ, Estabrooks PA, Warne TM, Merle JL, Adams AK. Documenting two decades of longitudinal changes to a community-engaged obesity prevention intervention for Native American families to facilitate scale-up. Transl Behav Med. 2026 Jan 7;16(1):ibag056. doi: 10.1093/tbm/ibag056.
PubMed 42663129Tomayko EJ, Webber EJ, Cronin KA, Prince RJ, Adams AK. Use of Text Messaging and Facebook Groups to Support the Healthy Children, Strong Families 2 Healthy Lifestyle Intervention for American Indian Families. Curr Dev Nutr. 2021 May 17;5(Suppl 4):32-39. doi: 10.1093/cdn/nzaa110. eCollection 2021 Jun.
PubMed 34222765Rink E, Knight K, Ellis C, McCormick A, FireMoon P, Held S, Webber E, Adams A. Using Community-Based Participatory Research to Design, Conduct, and Evaluate Randomized Controlled Trials with American Indian Communities. Prev Chronic Dis. 2020 Nov 12;17:E143. doi: 10.5888/pcd17.200099.
PubMed 33180688Tomayko EJ, Prince RJ, Cronin KA, Kim K, Parker T, Adams AK. The Healthy Children, Strong Families 2 (HCSF2) Randomized Controlled Trial Improved Healthy Behaviors in American Indian Families with Young Children. Curr Dev Nutr. 2018 Nov 16;3(Suppl 2):53-62. doi: 10.1093/cdn/nzy087. eCollection 2019 Aug.
PubMed 31453428Grant VM, Tomayko EJ, Prince RJ, Cronin K, Adams A. Understanding Correlates of Physical Activity in American Indian Families: The Healthy Children Strong Families-2 Study. J Phys Act Health. 2018 Nov 1;15(11):866-873. doi: 10.1123/jpah.2017-0584. Epub 2018 Oct 19.
PubMed 30336717Tomayko EJ, Mosso KL, Cronin KA, Carmichael L, Kim K, Parker T, Yaroch AL, Adams AK. Household food insecurity and dietary patterns in rural and urban American Indian families with young children. BMC Public Health. 2017 Jun 30;17(1):611. doi: 10.1186/s12889-017-4498-y.
PubMed 28666476
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Children, Strong Families: American Indian Communities Preventing Obesity
- ClinicalTrials.gov ID
- NCT01776255
- Acronym / sponsor ID
- HCSF2 / 2012-0578
- Conditions
- Obesity, Overweight
- Keywords
- Obesity, Overweight, Lifestyle, American Indian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2013 (actual)
- Primary completion
- 27 Apr 2017 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 28 Jan 2013 (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.
Healthy Children, Strong Families-2 (HCSF-2) is a family focused early childhood intervention which addresses the growing problem of childhood obesity in American Indian communities. The study works with six rural and urban American Indian communities across the US to test the ability of the intervention to increase adoption of healthy lifestyles and to reduce the prevalence of obesity among preschool aged American Indian children and their primary caregivers - creating healthier children, healthier families and healthier communities. Our primary hypothesis is that children and their primary caregivers who receive the HCSF-2 intervention will have better obesity related outcomes than those who do not receive HCSF-2.
Detailed description
Intervention
The Healthy Children, Strong Families-2 (HCSF-2) intervention consists of monthly mailed healthy lifestyle lessons (13 lessons) which will be dose enhanced with social networking support (cell-phone coaching with instant text messages and Facebook connections), as well as new intervention elements-stress and sleep. Social networking was chosen due to its widespread and ease of use, adaptability and potential for sustainability in the community.
HCSF-2 is based on our hypothesis that working with children and their primary caregivers/parent to assist them in making healthy lifestyle changes is necessary to prevent excessive weight gain and risk of later lifestyle related chronic disease. Investigators will work with families at a critical time in their young child's physical and emotional development to encourage appropriate healthy lifestyle behaviors.
This study will expand on our previous research to test the HCSF-2 intervention in a larger, more geographically and socially diverse sample of AI communities. The study also enhances the prior methodology through the inclusion of a social networking component. This research will address four key gaps in obesity prevention studies: families with preschool age children, social networking support, stress and sleep. Moreover, to our knowledge, this study will be the first family-based obesity intervention project for both rural and urban AI families. The potential impact of this study is high; if successful, this study will not only provide quantitative evidence of the effectiveness of the intervention but it will also give other investigators validated tools and procedures to collaboratively engage AI communities in health behavior change.
Year 1, families will be randomized to start in the HCSF-2 intervention or an active control (mailed child safety newsletters). Then, in Year 2, intervention change will occur, such that HCSF-2 intervention families will receive the control safety lessons plus continued HCSF-2 social networking, while control families will now receive the full HCSF-2 intervention.
For example, families will be randomly assigned to begin in one of the two arms - denoted here as the HCSF-2 intervention (Phase A) or Child Safety intervention (Phase B).
During the HCSF-2 intervention (Phase A) families will receive a monthly mailing with information about nutrition and physical activity, screen time, sleep and stress management. Families will also be invited to participate in a private Facebook group and will begin receiving wellness coaching text messages from the study.
During the Child Safety intervention (Phase B) families will receive a monthly mailing with information about safety topics such as car safety, water safety, poisoning and home safety.
After one year, families will flip into the second phase until the two year study period is complete. Families who began in Phase A will continue to receive wellness coaching text messages and have access to the private Facebook group. Families who began in Phase B will not receive wellness coaching text messages or have access to the private Facebook group until the flip into Phase A at the start of year two.
This staggered enrollment design, chosen in conjunction with the participating communities, maximizes the contribution of each participating family, avoids the negative attitudes that would occur with a wait-list only control and ensures all families receive the intervention as desired by the participating tribal sites.
This is a multi-site trial with up to six possible participating communities. Two sites will become active at the beginning of the intervention with remaining sites becoming active (and being added to the IRB protocol) at roughly 1 year intervals.
A local site coordinator will be hired at each participating site. The local site coordinator will be responsible for recruiting participants, and conducting data collection visits. Site coordinators may also send wellness coaching text messages and post content to the private Facebook group.
The UW program coordinator will be responsible for screening participants for eligibility, administering 24-hour dietary recalls by phone, mailing HCSF-2 curriculum materials and Child Safety materials, managing the entry and storage of study data, sending results letters to participants and supporting the community site coordinators.
Methods
Investigators will partner with 6 diverse rural and urban AI communities nationally to conduct a 2-arm staggered-enrollment randomized trial of an enhanced version of the HCSF intervention (HCSF-2) vs. active control (Child Safety intervention) in a 2-year design with outcomes measured at 0, 6, 12, 18 and 24 months. At the end of year 1, control families will receive HCSF-2, and HCSF-2 families will receive the control intervention with continued HCSF-2 social network support. Communities will work with us to enhance the family-focused HCSF-2 intervention to include novel methods of delivery (mailed lessons with social networking/cell phone text coaching) and two less-studied obesity determinants-sleep and stress-to increase impact and sustainability.
Outcomes
Primary outcomes will be body fat as assessed by child Body Mass Index z-score (zBMI) and adult Body Mass Index (BMI). Secondary outcomes include adult and child waist circumference, fruit/vegetable (FV) and added sugar intake, TV/screen time, activity, sleep, home environment changes, adult psychosocial factors (stress/depression) and social network use.
Investigators will also identify key mediators of the effect of HCSF-2 on obesity and health behaviors. We hypothesize that modifiable behavior changes in children and caregivers, adult self-efficacy, social support and home environment changes are important mediators of the effect of the intervention on obesity and other outcomes. Investigators will develop and test exploratory mixed-effects regression models to investigate mediation on the path from HCSF-2 to weight reduction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Children, Strong Families (first) | Experimental | Behavioral: Healthy Children, Strong Families, Behavioral: Child SafetyHealthy Children, Strong Families intervention (first). This is a series of monthly educational tool kits mailed to primary caregivers for use with the participating child. This arm crosses over to receive the Child Safety in Year 2. |
| Child Safety (first) | Active comparator | Behavioral: Healthy Children, Strong Families, Behavioral: Child SafetyA series of 12 monthly newsletters and providing education on child safety mailed to primary caregivers. This Arm crosses over to receive the Healthy Children, Strong Families intervention in Year 2. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Adult caregiver with a 2-5 year old child
- 2-5 year old child with a caregiver
- Caregiver has a working cell phone and is willing to receive regular text messages as part of study participation
- Caregiver lives within feasible travel distance of data collection site and willing to come for data collection visits at 0, 6 months, 12 months, 18 months and 24 months
- Willingness to be randomized to one of two groups with the understanding that all participants will receive all components of the intervention, randomization simply determines the order in which materials are received
Key exclusion criteria (8 listed)
- Adults with no children or whose only children are younger than 2 or older than 5
- Children younger than 2 or older than 5 years of age
- No cell phone or unwilling to receive regular text messages as part of study participation
- Lives beyond feasible travel distance of data collection sites AND/OR planning on moving out of the area within a two year period
- Child has major physical or behavioral disorder (e.g. failure to thrive, severe autism) that would seriously impact study participation
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 |
|---|---|---|
| Healthy Children, Strong FamiliesHealthy Children, Strong Families is a series of 13 "lessons" mailed to primary caregivers of preschool aged children that provide education and activities related to obesity prevention. The lessons cover topics related to nutrition, physical activity, stress, sleep, and the home environment. Lessons include printed materials and small items (for example, an apple sectioner) that support activities in the lessons. Social support components via a monitored Facebook group and approximately semiweekly text messages sent to caregivers are included. The intervention spans 1 year. | Behavioural | Child Safety (first), Healthy Children, Strong Families (first) |
| Child SafetyThe Child Safety intervention is an active control condition consisting of monthly two-page newsletters covering various topics relevant to child safety such as choking, car safety seats, bike and pedestrian safety. The intervention spans 1 year. | Behavioural | Child Safety (first), Healthy Children, Strong Families (first) |
Primary outcome
Change in child adiposity from baseline measured via BMI z-score
Time frame: Enrollment, 6 months, 12 months, 18 months, 24 months
BMI z-score is obtained by computing the BMI weight (in kg)/height (in m)*height (in m). BMI is then converted to a z-score based on US national norms for gender and age in months provided
Change in adult adiposity from baseline measured via BMI
Time frame: Enrollment, 12 months, 24 months
Adult BMI is computed from weight (in kg) divided by height (in m) squared
14 secondary outcomes
Change in child adiposity from baseline measured via waist circumference
Time frame: Enrollment, 6 months, 12 months, 18 months, 24 months
Change in adult adiposity from baseline measured via waist circumference
Time frame: Enrollment, 12 months, 24 months
Change in child fruit and vegetable consumption from baseline
Time frame: Enrollment, 12 months, 24 months
Change in adult fruit and vegetable consumption from basline
Time frame: Enrollment, 12 months, 24 months
Change in amount of child screen time from basline
Time frame: Enrollment, 12 month, 24 month
Change in amount of adult screen time from basline
Time frame: Enrollment, 12 month, 24 month
Change in amount of child physical activity from baseline
Time frame: Enrollment, 12 months, 24 months
Change in amount of adult physical activity from basline
Time frame: Enrollment, 12 months, 24 months
Change in child sleep pattern from basline
Time frame: Enrollment, 12 months, 24 months
Change in home environment from basline
Time frame: Enrollment, 12 months, 24 months
Change in adult Readiness to Change from basline
Time frame: Enrollment, 6 months, 12 months, 18 months, 24 months
Change in adult SF-12 scores from basline
Time frame: Enrollment, 12 months, 24 months
Stress questionnaire
Time frame: Enrollment, 12 months, 24 months
Change in adult sleep pattern from basline
Time frame: Enrollment, 12 months, 24 months
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 26 Oct 2017.
- Background: PubMed 22956296Adams AK, LaRowe TL, Cronin KA, Prince RJ, Wubben DP, Parker T, Jobe JB. The Healthy Children, Strong Families intervention: design and community participation. J Prim Prev. 2012 Aug;33(4):175-85. doi: 10.1007/s10935-012-0275-y.
- Background: PubMed 22983753Jobe JB, Adams AK, Henderson JA, Karanja N, Lee ET, Walters KL. Community-responsive interventions to reduce cardiovascular risk in American Indians. J Prim Prev. 2012 Aug;33(4):153-9. doi: 10.1007/s10935-012-0277-9.
- Background: PubMed 17875253LaRowe TL, Wubben DP, Cronin KA, Vannatter SM, Adams AK. Development of a culturally appropriate, home-based nutrition and physical activity curriculum for Wisconsin American Indian families. Prev Chronic Dis. 2007 Oct;4(4):A109. Epub 2007 Sep 15.
- Derived from this study: PubMed 42663129Tomayko EJ, Estabrooks PA, Warne TM, Merle JL, Adams AK. Documenting two decades of longitudinal changes to a community-engaged obesity prevention intervention for Native American families to facilitate scale-up. Transl Behav Med. 2026 Jan 7;16(1):ibag056. doi: 10.1093/tbm/ibag056.
- Derived from this study: PubMed 34222765Tomayko EJ, Webber EJ, Cronin KA, Prince RJ, Adams AK. Use of Text Messaging and Facebook Groups to Support the Healthy Children, Strong Families 2 Healthy Lifestyle Intervention for American Indian Families. Curr Dev Nutr. 2021 May 17;5(Suppl 4):32-39. doi: 10.1093/cdn/nzaa110. eCollection 2021 Jun.
- Derived from this study: PubMed 33180688Rink E, Knight K, Ellis C, McCormick A, FireMoon P, Held S, Webber E, Adams A. Using Community-Based Participatory Research to Design, Conduct, and Evaluate Randomized Controlled Trials with American Indian Communities. Prev Chronic Dis. 2020 Nov 12;17:E143. doi: 10.5888/pcd17.200099.
- Derived from this study: PubMed 31453428Tomayko EJ, Prince RJ, Cronin KA, Kim K, Parker T, Adams AK. The Healthy Children, Strong Families 2 (HCSF2) Randomized Controlled Trial Improved Healthy Behaviors in American Indian Families with Young Children. Curr Dev Nutr. 2018 Nov 16;3(Suppl 2):53-62. doi: 10.1093/cdn/nzy087. eCollection 2019 Aug.
- Derived from this study: PubMed 30336717Grant VM, Tomayko EJ, Prince RJ, Cronin K, Adams A. Understanding Correlates of Physical Activity in American Indian Families: The Healthy Children Strong Families-2 Study. J Phys Act Health. 2018 Nov 1;15(11):866-873. doi: 10.1123/jpah.2017-0584. Epub 2018 Oct 19.
- Derived from this study: PubMed 28666476Tomayko EJ, Mosso KL, Cronin KA, Carmichael L, Kim K, Parker T, Yaroch AL, Adams AK. Household food insecurity and dietary patterns in rural and urban American Indian families with young children. BMC Public Health. 2017 Jun 30;17(1):611. doi: 10.1186/s12889-017-4498-y.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Alexandra K Adams, MD, PhD principal investigator
University of Wisconsin, Madison
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Children, Strong Families and Child Safety in people with Obesity and Overweight, run by University of Wisconsin, Madison at 5 sites 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 8 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 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Change in child adiposity from baseline measured via BMI z-score (time frame: Enrollment, 6 months, 12 months, 18 months, 24 months). The study lists 2 primary outcomes in all. 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 NCT01776255, which also lists 9 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 26 Oct 2017.