Developing a Preschool Obesity Intervention for Families Enrolled in WIC

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).

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity
• Intervention / Treatment: Behavioral: Family-Based Weight Control

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family-Based Weight Control Intervention; Families will receive the FBWC	Behavioral: Family-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.; Other Names: FBWC
No Intervention: Control; Families will continue with standard of care at WIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility (attendance and attrition)	mean number of sessions attended and number of families who dropped out of the intervention	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.	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.	7 months
Change in preschooler BMI z-score	based upon height and weight	baseline, 4 months, 7 months
Change in and caregiver BMI	based upon height and weight	baseline, 4 months, 7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in preschooler diet	24-hour dietary recall	baseline, 4-months, 7-months
Change in preschooler activity	accelerometry	baseline, 4-months, 7-months
Change in caregiver diet	Block Brief Questionnaire	baseline, 4-months, 7-months
Change in caregiver activity	Paffenbarger Activity Questionnaire	baseline, 4-months, 7-months
Change in caregiver feeding	Child Feeding Questionnaire, Caregiver's Feeding Style Questionnaire	baseline, 4-months, 7-months
Change in caregiver stress	Perceived Stress Scale	baseline, 4-months, 7-months
Change in home food environment	observational measure of energy- and nutrient-dense foods in the home	baseline, 4-months, 7-months

Collaborators and Investigators

• Sponsor: Wayne State University
• Collaborators: Michigan Department of Community Health

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): January 31, 2017
• Study Completion (Actual): January 31, 2017

Study Registration Dates

• First Submitted: November 9, 2014
• First Submitted That Met QC Criteria: November 14, 2014
• First Posted (Estimate): November 17, 2014

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: obesity; preschool; intervention; health disparities
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 1R21HD078890-01 (U.S. NIH Grant/Contract)