Wayne State University
Detroit, Michigan, 48201, United States
NCT Number: NCT02292602
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).
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Notify Me24 month–55 month
All sexes
Interventional
Not applicable
Detroit, Michigan, 48201, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 4-months
mean number of sessions attended and number of families who dropped out of the intervention
Time frame: 4 months
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: 7 months
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: baseline, 4 months, 7 months
based upon height and weight
Time frame: baseline, 4 months, 7 months
based upon height and weight
Time frame: baseline, 4-months, 7-months
24-hour dietary recall
Time frame: baseline, 4-months, 7-months
accelerometry
Time frame: baseline, 4-months, 7-months
Block Brief Questionnaire
Time frame: baseline, 4-months, 7-months
Paffenbarger Activity Questionnaire
Time frame: baseline, 4-months, 7-months
Child Feeding Questionnaire, Caregiver's Feeding Style Questionnaire
Time frame: baseline, 4-months, 7-months
Perceived Stress Scale
Time frame: baseline, 4-months, 7-months
observational measure of energy- and nutrient-dense foods in the home
Wayne State University
Other
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