Pediatric ObesityNCT02292602
Developing a Preschool Obesity Intervention for Families Enrolled in WIC
A study of Pediatric Obesity, run by Wayne State University at 1 site in United States.
Trial summary
The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a community and home-based preschool obesity intervention for families enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Read more about this study
- Who is it for?
- Ages 24 to 55 months
- Conditions the study is for
- Pediatric Obesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 31 Jan 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 24 to 55 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- family receiving services at Detroit-based WIC clinics
- preschooler between the ages of 2 years and 4 years, 7 months and BMI>85th percentile
- one primary caregiver who is willing to participate and whose BMI>25
- family is English-speaking
- preschooler has medical clearance to participate in the intervention
- caregiver has medical clearance to participate in the intervention if indicated by physical activity screening questions
Who cannot join
- preschooler or caregiver is participating in a different weight management program
- preschooler or caregiver has a condition that precludes participation in moderate level activity
- preschooler or caregiver is diagnosed with a weight-affecting health condition
- preschooler or caregiver is taking weight-affecting medications
- preschooler or caregiver is diagnosed with a developmental delay or disability
- caregiver is receiving treatment for severe psychopathology
- family plans to be out of town for more than 2 weeks of the first 4 months of their research participation
- family plans to move from Detroit in the next 7 months
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a community and home-based preschool obesity intervention for families enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
Read the detailed description
Very few studies have targeted weight control in preschoolers even though the prevalence of overweight has exceeded 20% in this age-group for the past decade. Also concerning is that few studies have focused on preschoolers from low-socioeconomic (SES) backgrounds despite persistent obesity-related socioeconomic disparities. Family-based, behavioral interventions appear a promising model for treatment of obesity in early childhood. However, the dissemination potential of these programs is unclear as they have primarily been tested with families from middle-to-upper class backgrounds and within research settings. Identifying effective approaches to weight control for preschoolers from low-SES backgrounds that can be delivered in community settings is imperative to reducing the pediatric obesity epidemic. The proposed study will begin to address this critical gap by completing the second phase of developing a community-based preschool weight control intervention for families enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). The proposed study is significant because we specifically target preschool weight control in a high-risk population and because delivery of our program within the WIC program is conducive to its dissemination. Based upon our formative work, and existing preschool obesity programs, we have developed a 14-session, family-based preschool weight control intervention (FBWC) that emphasizes experiential learning and is delivered in the WIC and home settings. Seventy-two overweight and obese preschool-caregiver dyads will be randomized in a 2:1 ratio to receive FBWC or to continue with standard of care at WIC (WSOC). The primary study aims are to a) examine the feasibility and acceptability of FBWC and b) explore the preliminary efficacy of FBWC compared to WSOC on reduction in preschooler BMI-z-score and caregiver BMI from baseline to post-treatment (4-months) and 7-months (3-month follow-up). An exploratory aim is to evaluate lifestyle and behavioral indicators of intervention success. This study is innovative because: 1) very few studies have examined obesity intervention in preschoolers, 2) we target weight control in a high-risk group that has been underrepresented in the preschool obesity treatment outcome literature, 3) our intervention is community-based, and 4) we emphasize experiential learning as a strategy for achieving lifestyle behavior change and weight control.
- Conditions
- Pediatric Obesity
- Being tested
- Family-Based Weight Control
- Keywords
- preschool, obesity, health disparities, intervention
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-Based Weight ControlBehavioural
Also called FBWC
Families randomized to the intervention condition will receive a 4-month, 14-session behavioral weight control intervention targeting obesity reduction in preschoolers and caregivers. Within the program, 9 sessions will be group-based and held at WIC and 5 sessions will be individual visits (4 home-based and 1 at a food market where the family shops). The intervention includes teaching behavioral weight loss, child behavior management, and life skills (e.g., budgeting and time management ) via experiential learning to assist families with implementing diet and activity recommendations for pediatric and adult weight management.
| Study group | Role | What they receive |
|---|---|---|
| Family-Based Weight Control Intervention | Experimental | Families will receive the FBWC Receives: Behavioral: Family-Based Weight Control |
| Control | No intervention | Families will continue with standard of care at WIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (attendance and attrition)
mean number of sessions attended and number of families who dropped out of the intervention
Measured: 4-months
Perceived acceptability of the program at post-treatment as measured by semi-structured qualitative interviews
Semi-structured qualitative interviews will be conducted with a randomly selected subset of families completing the intervention (n=12) to determine whether the intervention met their needs.
Measured: 4 months
Perceived acceptability of the program at follow-up
Semi-structured qualitative interviews will be conducted with a randomly selected subset of families completing the intervention (n=24) to determine whether intervention content facilitated sustained change.
Measured: 7 months
Change in preschooler BMI z-score
based upon height and weight
Measured: baseline, 4 months, 7 months
Change in and caregiver BMI
based upon height and weight
Measured: baseline, 4 months, 7 months
Secondary outcomes (7)
Change in preschooler diet
24-hour dietary recall
Measured: baseline, 4-months, 7-months
Change in preschooler activity
accelerometry
Measured: baseline, 4-months, 7-months
Change in caregiver diet
Block Brief Questionnaire
Measured: baseline, 4-months, 7-months
Change in caregiver activity
Paffenbarger Activity Questionnaire
Measured: baseline, 4-months, 7-months
Change in caregiver feeding
Child Feeding Questionnaire, Caregiver's Feeding Style Questionnaire
Measured: baseline, 4-months, 7-months
Change in caregiver stress
Perceived Stress Scale
Measured: baseline, 4-months, 7-months
Change in home food environment
observational measure of energy- and nutrient-dense foods in the home
Measured: baseline, 4-months, 7-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startFeb 2014
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Department of Community Health
- Responsible party
- Principal investigator, Elizabeth Kuhl, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292602
- Sponsor's protocol ID
- 1R21HD078890-01
- Status last verified
- May 2017
- First submitted
- 9 Nov 2014
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Preschool Obesity Intervention for Families Enrolled in WIC
- ClinicalTrials.gov ID
- NCT02292602
- Acronym / sponsor ID
- 1R21HD078890-01
- Conditions
- Pediatric Obesity
- Keywords
- preschool, obesity, health disparities, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- Michigan Department of Community Health
- Study start
- Feb 2014
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 17 Nov 2014 (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 purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a community and home-based preschool obesity intervention for families enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
Detailed description
Very few studies have targeted weight control in preschoolers even though the prevalence of overweight has exceeded 20% in this age-group for the past decade. Also concerning is that few studies have focused on preschoolers from low-socioeconomic (SES) backgrounds despite persistent obesity-related socioeconomic disparities. Family-based, behavioral interventions appear a promising model for treatment of obesity in early childhood. However, the dissemination potential of these programs is unclear as they have primarily been tested with families from middle-to-upper class backgrounds and within research settings. Identifying effective approaches to weight control for preschoolers from low-SES backgrounds that can be delivered in community settings is imperative to reducing the pediatric obesity epidemic. The proposed study will begin to address this critical gap by completing the second phase of developing a community-based preschool weight control intervention for families enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). The proposed study is significant because we specifically target preschool weight control in a high-risk population and because delivery of our program within the WIC program is conducive to its dissemination. Based upon our formative work, and existing preschool obesity programs, we have developed a 14-session, family-based preschool weight control intervention (FBWC) that emphasizes experiential learning and is delivered in the WIC and home settings. Seventy-two overweight and obese preschool-caregiver dyads will be randomized in a 2:1 ratio to receive FBWC or to continue with standard of care at WIC (WSOC). The primary study aims are to a) examine the feasibility and acceptability of FBWC and b) explore the preliminary efficacy of FBWC compared to WSOC on reduction in preschooler BMI-z-score and caregiver BMI from baseline to post-treatment (4-months) and 7-months (3-month follow-up). An exploratory aim is to evaluate lifestyle and behavioral indicators of intervention success. This study is innovative because: 1) very few studies have examined obesity intervention in preschoolers, 2) we target weight control in a high-risk group that has been underrepresented in the preschool obesity treatment outcome literature, 3) our intervention is community-based, and 4) we emphasize experiential learning as a strategy for achieving lifestyle behavior change and weight control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family-Based Weight Control Intervention | Experimental | Behavioral: Family-Based Weight ControlFamilies will receive the FBWC |
| Control | No intervention | –Families will continue with standard of care at WIC |
Who may qualify
- Ages
- 24 to 55 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- family receiving services at Detroit-based WIC clinics
- preschooler between the ages of 2 years and 4 years, 7 months and BMI>85th percentile
- one primary caregiver who is willing to participate and whose BMI>25
- family is English-speaking
- preschooler has medical clearance to participate in the intervention
Key exclusion criteria (8 listed)
- preschooler or caregiver is participating in a different weight management program
- preschooler or caregiver has a condition that precludes participation in moderate level activity
- preschooler or caregiver is diagnosed with a weight-affecting health condition
- preschooler or caregiver is taking weight-affecting medications
- preschooler or caregiver is diagnosed with a developmental delay or disability
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 |
|---|---|---|
| Family-Based Weight ControlAlso: FBWCFamilies randomized to the intervention condition will receive a 4-month, 14-session behavioral weight control intervention targeting obesity reduction in preschoolers and caregivers. Within the program, 9 sessions will be group-based and held at WIC and 5 sessions will be individual visits (4 home-based and 1 at a food market where the family shops). The intervention includes teaching behavioral weight loss, child behavior management, and life skills (e.g., budgeting and time management ) via experiential learning to assist families with implementing diet and activity recommendations for pediatric and adult weight management. | Behavioural | Family-Based Weight Control Intervention |
Primary outcome
Feasibility (attendance and attrition)
Time frame: 4-months
mean number of sessions attended and number of families who dropped out of the intervention
Perceived acceptability of the program at post-treatment as measured by semi-structured qualitative interviews
Time frame: 4 months
Semi-structured qualitative interviews will be conducted with a randomly selected subset of families completing the intervention (n=12) to determine whether the intervention met their needs.
Perceived acceptability of the program at follow-up
Time frame: 7 months
Semi-structured qualitative interviews will be conducted with a randomly selected subset of families completing the intervention (n=24) to determine whether intervention content facilitated sustained change.
Change in preschooler BMI z-score
Time frame: baseline, 4 months, 7 months
based upon height and weight
Change in and caregiver BMI
Time frame: baseline, 4 months, 7 months
based upon height and weight
7 secondary outcomes
Change in preschooler diet
Time frame: baseline, 4-months, 7-months
Change in preschooler activity
Time frame: baseline, 4-months, 7-months
Change in caregiver diet
Time frame: baseline, 4-months, 7-months
Change in caregiver activity
Time frame: baseline, 4-months, 7-months
Change in caregiver feeding
Time frame: baseline, 4-months, 7-months
Change in caregiver stress
Time frame: baseline, 4-months, 7-months
Change in home food environment
Time frame: baseline, 4-months, 7-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 9 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pediatric Obesity, run by Wayne State University 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 6 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 9 May 2017. 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?
Feasibility (attendance and attrition) (time frame: 4-months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2017.