Developing a Preschool Obesity Intervention for Families Enrolled in WIC
Primary Purpose
Pediatric Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-Based Weight Control
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Obesity focused on measuring preschool, obesity, health disparities, intervention
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
Sites / Locations
- Wayne State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Family-Based Weight Control Intervention
Control
Arm Description
Families will receive the FBWC
Families will continue with standard of care at WIC
Outcomes
Primary Outcome Measures
Feasibility (attendance and attrition)
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
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
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
based upon height and weight
Change in and caregiver BMI
based upon height and weight
Secondary Outcome Measures
Change in preschooler diet
24-hour dietary recall
Change in preschooler activity
accelerometry
Change in caregiver diet
Block Brief Questionnaire
Change in caregiver activity
Paffenbarger Activity Questionnaire
Change in caregiver feeding
Child Feeding Questionnaire, Caregiver's Feeding Style Questionnaire
Change in caregiver stress
Perceived Stress Scale
Change in home food environment
observational measure of energy- and nutrient-dense foods in the home
Full Information
NCT ID
NCT02292602
First Posted
November 9, 2014
Last Updated
May 8, 2017
Sponsor
Wayne State University
Collaborators
Michigan Department of Community Health
1. Study Identification
Unique Protocol Identification Number
NCT02292602
Brief Title
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
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
January 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
Michigan Department of Community Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
preschool, obesity, health disparities, intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Family-Based Weight Control Intervention
Arm Type
Experimental
Arm Description
Families will receive the FBWC
Arm Title
Control
Arm Type
No Intervention
Arm Description
Families will continue with standard of care at WIC
Intervention Type
Behavioral
Intervention Name(s)
Family-Based Weight Control
Other Intervention Name(s)
FBWC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility (attendance and attrition)
Description
mean number of sessions attended and number of families who dropped out of the intervention
Time Frame
4-months
Title
Perceived acceptability of the program at post-treatment as measured by semi-structured qualitative interviews
Description
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.
Time Frame
4 months
Title
Perceived acceptability of the program at follow-up
Description
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.
Time Frame
7 months
Title
Change in preschooler BMI z-score
Description
based upon height and weight
Time Frame
baseline, 4 months, 7 months
Title
Change in and caregiver BMI
Description
based upon height and weight
Time Frame
baseline, 4 months, 7 months
Secondary Outcome Measure Information:
Title
Change in preschooler diet
Description
24-hour dietary recall
Time Frame
baseline, 4-months, 7-months
Title
Change in preschooler activity
Description
accelerometry
Time Frame
baseline, 4-months, 7-months
Title
Change in caregiver diet
Description
Block Brief Questionnaire
Time Frame
baseline, 4-months, 7-months
Title
Change in caregiver activity
Description
Paffenbarger Activity Questionnaire
Time Frame
baseline, 4-months, 7-months
Title
Change in caregiver feeding
Description
Child Feeding Questionnaire, Caregiver's Feeding Style Questionnaire
Time Frame
baseline, 4-months, 7-months
Title
Change in caregiver stress
Description
Perceived Stress Scale
Time Frame
baseline, 4-months, 7-months
Title
Change in home food environment
Description
observational measure of energy- and nutrient-dense foods in the home
Time Frame
baseline, 4-months, 7-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
55 Months
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
12. IPD Sharing Statement
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Developing a Preschool Obesity Intervention for Families Enrolled in WIC
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