Families and Schools for Health (FiSH)

Amanda Harrist

Status

Completed

Conditions

Overweight

Pediatric Obesity

Treatments

Behavioral: Family Lifestyle (FL)

Behavioral: Family Dynamics (FD)

Behavioral: Peer Group (PG)

Study type

Interventional

Funder types

Other

Identifiers

NCT02659319

HR07-044, HR08-043 (Other Grant/Funding Number)

NIFA/USDA Agreement No. 05545

Details and patient eligibility

About

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.

Full 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.

Enrollment

541 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Children with BMI% greater than or equal to 75% who were enrolled in first grade in participating schools.

Exclusion criteria

Children with BMI% < 75%.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

541 participants in 5 patient groups

Family Lifestyle (FL; n = 117)

Experimental group

Description:

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.

Treatment:

Behavioral: Family Lifestyle (FL)

FL + Family Dynamics (FL+FD; n = 88)

Experimental group

Description:

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.

Treatment:

Behavioral: Family Lifestyle (FL)

Behavioral: Family Dynamics (FD)

FL + Peer Group (FL+PG; n = 124)

Experimental group

Description:

This arm includes the Family Food \& Lifestyle intervention plus the 12-session, Peer Group intervention.

Treatment:

Behavioral: Family Lifestyle (FL)

Behavioral: Peer Group (PG)

FL + FD + Peer Group (FL+FD+PG; n = 130)

Experimental group