Skip to content

Developing a Preschool Obesity Intervention for Families Enrolled in WIC

Developing a Preschool Obesity Intervention for Families Enrolled in WIC

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02292602
Enrollment
19
Registered
2014-11-17
Start date
2014-02-28
Completion date
2017-01-31
Last updated
2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Obesity

Keywords

preschool, obesity, health disparities, intervention

Brief 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).

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.

Interventions

BEHAVIORALFamily-Based Weight Control

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.

Sponsors

Michigan Department of Community Health
CollaboratorOTHER
Wayne State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
24 Months to 55 Months
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility (attendance and attrition)4-monthsmean 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 interviews4 monthsSemi-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-up7 monthsSemi-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-scorebaseline, 4 months, 7 monthsbased upon height and weight
Change in and caregiver BMIbaseline, 4 months, 7 monthsbased upon height and weight

Secondary

MeasureTime frameDescription
Change in caregiver stressbaseline, 4-months, 7-monthsPerceived Stress Scale
Change in preschooler dietbaseline, 4-months, 7-months24-hour dietary recall
Change in home food environmentbaseline, 4-months, 7-monthsobservational measure of energy- and nutrient-dense foods in the home
Change in preschooler activitybaseline, 4-months, 7-monthsaccelerometry
Change in caregiver dietbaseline, 4-months, 7-monthsBlock Brief Questionnaire
Change in caregiver activitybaseline, 4-months, 7-monthsPaffenbarger Activity Questionnaire
Change in caregiver feedingbaseline, 4-months, 7-monthsChild Feeding Questionnaire, Caregiver's Feeding Style Questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026