Families and Schools for Health
- Conditions
- OverweightPediatric Obesity
- Interventions
- Behavioral: Family Lifestyle (FL)Behavioral: Family Dynamics (FD)Behavioral: Peer Group (PG)
- Registration Number
- NCT02659319
- Lead Sponsor
- Amanda Harrist
- Brief Summary
The purpose of the study is to test the effectiveness of a child obesity intervention with multiple components targeting nutrition and/or psycho-social factors in children, their parents, and their classmates. The specific aims of the study are to (1) Determine the effectiveness of two family-level interventions for improving child outcomes (unhealthy eating, low activity, and overweight); (2) Determine the extent to which adding a family dynamics component enhances the effectiveness of a family lifestyle intervention and improves the child outcomes listed above; and (3) Determine the extent to which a peer-level intervention improves the effectiveness of two family-level interventions among overweight children.
- Detailed Description
The Families and Schools for Health (FiSH) Project evaluates a psychosocial intervention that targets the family and peer contexts of overweight children. 23 rural schools were identified for participation (schools within a 90-mile radius of the PI's campus were targeted) and each was assigned to one of five intervention conditions using stratified random sampling, with stratification based on proximity to each other (to avoid spill-over effects) and proportion of Native American Indian students. A community sample of 1186 1st grade children, their families, and their teachers were successfully recruited. Anthropometric assessments were conducted with the 1186 children. Those who were not at Control schools were invited to participate in the intervention. 541 children qualified for the intervention (i.e., had BMI% \> 75%), including 459 at Intervention schools and 82 at Control schools. Intervention conditions were (1) a 12-week Family Food \& Lifestyle intervention (FL), aimed at improving family nutritional intake, activity levels, weight perception, and parental monitoring of child eating; (2) a 12-week Family Food \& Lifestyle and Family Dynamics intervention (FL+FD) that additionally targets dysfunctional family patterns such as high conflict, poor parent-child communication, and parental over-control or permissiveness; and (3) a Peer Group (PG) intervention conducted throughout one semester of the school year that includes a guidance-type curriculum sensitizing children to the importance of social inclusion of all children. Thus, 5 treatment groups were evaluated in the intervention year and followed through 4th grade: FL, FL+FD, FL+PG, FL+FD+PG, and Control. Child psychosocial variables such as emotional eating, self-esteem, loneliness, and social withdrawal will be analyzed as mediators between family/peer contexts and child overweight.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 541
- Children with BMI% greater than or equal to 75% who were enrolled in first grade in participating schools.
- Children with BMI% < 75%.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description FL + Peer Group (FL+PG; n = 124) Family Lifestyle (FL) This arm includes the Family Food \& Lifestyle intervention plus the 12-session, Peer Group intervention. FL + FD + Peer Group (FL+FD+PG; n = 130) Family Dynamics (FD) This arm includes the Family Food \& Lifestyle intervention plus the Family Dynamics Intervention plus the Peer Group intervention. FL + Family Dynamics (FL+FD; n = 88) Family Dynamics (FD) This arm includes the Family Food \& Lifestyle + Family Dynamics interventions (FL+FD). Parents and children meet separately for the full 90-minute psychoeducation sessions. The first 45 minutes are devoted to the Family Food \& Lifestyle intervention and the second 45 minutes to the Family Dynamics intervention. FL + Peer Group (FL+PG; n = 124) Peer Group (PG) This arm includes the Family Food \& Lifestyle intervention plus the 12-session, Peer Group intervention. FL + FD + Peer Group (FL+FD+PG; n = 130) Family Lifestyle (FL) This arm includes the Family Food \& Lifestyle intervention plus the Family Dynamics Intervention plus the Peer Group intervention. FL + FD + Peer Group (FL+FD+PG; n = 130) Peer Group (PG) This arm includes the Family Food \& Lifestyle intervention plus the Family Dynamics Intervention plus the Peer Group intervention. Family Lifestyle (FL; n = 117) Family Lifestyle (FL) This arm includes the Family Food \& Lifestyle intervention (FL). Parents and children meet for 12 weekly, 90-minute psychoeducational groups in children's schools. They meet separately for 45 minutes and then conjointly for 45 minutes. FL + Family Dynamics (FL+FD; n = 88) Family Lifestyle (FL) This arm includes the Family Food \& Lifestyle + Family Dynamics interventions (FL+FD). Parents and children meet separately for the full 90-minute psychoeducation sessions. The first 45 minutes are devoted to the Family Food \& Lifestyle intervention and the second 45 minutes to the Family Dynamics intervention.
- Primary Outcome Measures
Name Time Method Body Mass Change from Baseline to End of 1st grade Wave 2, Spring Year 1 Height and weight measured at Wave 2 (Spring 1st grade), vs. Baseline at Fall 1st grade
Body Mass Change from Baseline to End of 2nd grade Wave 3, Spring Year 2 Height and weight measured at Wave 3 (Spring 2nd grade), vs. Baseline at Wave 1, Fall 1st grade
Body Mass Change from Baseline to End of 3rd grade Wave 4, Spring Year 3 Height and weight measured at Wave 4 (Spring 3rd grade), vs. Baseline at Wave 1, Fall 1st grade
Body Mass Change from Baseline to End of 4th grade Wave 5, Spring Year 4 Height and weight measured at Wave 5 (Spring 4th grade) vs. Baseline at Wave 1, Fall 1st grade
- Secondary Outcome Measures
Name Time Method Child self esteem - child self report Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4 Child depressive symptoms - child self report Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4 Parenting style (permissive, authoritative, authoritarian) - parent report Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4 Parent perceived responsibility, weight, child weight, concerns about weight, feeding practices - parent report Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4 Parent expectations about, parent modeling of, and parent perception of child beliefs regarding eating - parent report Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4 Family problem solving, communication, affective responsiveness, affective involvement, & general family functioning - parent report Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4 Parent response to child negative emotions - parent report Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4 Child temperament - child and parent report Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4 Child emotion management - Parent and child report Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4 Child behavior problems - Parent and teacher report (externalizing, internalizing) Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4 School climate Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4 Peer relations - child, peer, and teacher reports Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4 Child emotional and external eating - child self report Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4 Body esteem - child self report Wave 1 Fall year 1, Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4