Clinical trial NCT02292602: Developing a Preschool Obesity Intervention for Families Enrolled in WIC
Official title: Developing a Preschool Obesity Intervention for Families Enrolled in WIC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: preschool
obesity
health disparities
intervention
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: Michigan Department of Community Health
First posted: 2014-11-17
Enrollment: 19
Sex: ALL
Minimum age (years): 24
Maximum age (years): 55
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility (attendance and attrition)
timeFrame: 4-months
measure: Perceived acceptability of the program at post-treatment as measured by semi-structured qualitative interviews
timeFrame: 4 months
measure: Perceived acceptability of the program at follow-up
timeFrame: 7 months
measure: Change in preschooler BMI z-score
timeFrame: baseline, 4 months, 7 months
measure: Change in and caregiver BMI
timeFrame: baseline, 4 months, 7 months
Secondary outcomes:
measure: Change in preschooler diet
timeFrame: baseline, 4-months, 7-months
measure: Change in preschooler activity
timeFrame: baseline, 4-months, 7-months
measure: Change in caregiver diet
timeFrame: baseline, 4-months, 7-months
measure: Change in caregiver activity
timeFrame: baseline, 4-months, 7-months
measure: Change in caregiver feeding
timeFrame: baseline, 4-months, 7-months
measure: Change in caregiver stress
timeFrame: baseline, 4-months, 7-months
measure: Change in home food environment
timeFrame: baseline, 4-months, 7-months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
References: