Developing a Preschool Obesity Intervention for Families Enrolled in WIC

NCT02292602 | Completed

• 1 other identifier: 1R21HD078890-01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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).

Conditions

Pediatric Obesity

Keywords

preschool; obesity; health disparities; intervention

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Change in preschooler diet

  baseline, 4-months, 7-months

• Change in preschooler activity

  baseline, 4-months, 7-months

• Change in caregiver diet

  baseline, 4-months, 7-months

• Change in caregiver activity

  baseline, 4-months, 7-months

• Change in caregiver feeding

  baseline, 4-months, 7-months

Study Arms (2)

Family-Based Weight Control Intervention

EXPERIMENTAL

Families will receive the FBWC

Behavioral: Family-Based Weight Control

Control

NO INTERVENTION

Families will continue with standard of care at WIC

Interventions

Family-Based Weight Control BEHAVIORAL

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.

Also known as: FBWC

Family-Based Weight Control Intervention

Eligibility Criteria

• Age: 24 Months - 55 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead
• Michigan Department of Community Health: collaborator

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: November 9, 2014
• First Posted: November 17, 2014
• Study Start: February 1, 2014
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

US (1)