Families and Schools for Health

NCT ID: NCT02659319

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 541 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2010-06-30

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.

Conditions

Overweight; Pediatric Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Family Lifestyle (FL; n = 117)

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.

Group Type: EXPERIMENTAL

Family Lifestyle (FL)

Intervention Type: BEHAVIORAL

12-week Family Food \& Lifestyle intervention, aimed at improving family nutritional intake, activity levels, weight perception, and parental monitoring of child eating. Material is delivered in psychoeducational groups in the children's schools.

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

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.

Group Type: EXPERIMENTAL

Family Lifestyle (FL)

Intervention Type: BEHAVIORAL

12-week Family Food \& Lifestyle intervention, aimed at improving family nutritional intake, activity levels, weight perception, and parental monitoring of child eating. Material is delivered in psychoeducational groups in the children's schools.

Family Dynamics (FD)

Intervention Type: BEHAVIORAL

The Family Dynamics intervention focuses on positive parenting (i.e., emotion coaching, praise, limit setting) and on child emotion regulation and positive problem solving. Material is delivered in psychoeducational groups in the children's schools.

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

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

Group Type: EXPERIMENTAL

Family Lifestyle (FL)

Intervention Type: BEHAVIORAL

12-week Family Food \& Lifestyle intervention, aimed at improving family nutritional intake, activity levels, weight perception, and parental monitoring of child eating. Material is delivered in psychoeducational groups in the children's schools.

Peer Group (PG)

Intervention Type: BEHAVIORAL

Peer Group intervention conducted throughout one semester of the school year that includes 12 sessions of a guidance-type curriculum during class time sensitizing children to the importance of social inclusion of all children

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

This arm includes the Family Food \& Lifestyle intervention plus the Family Dynamics Intervention plus the Peer Group intervention.

Group Type: EXPERIMENTAL

Family Lifestyle (FL)

Intervention Type: BEHAVIORAL

12-week Family Food \& Lifestyle intervention, aimed at improving family nutritional intake, activity levels, weight perception, and parental monitoring of child eating. Material is delivered in psychoeducational groups in the children's schools.

Family Dynamics (FD)

Intervention Type: BEHAVIORAL

The Family Dynamics intervention focuses on positive parenting (i.e., emotion coaching, praise, limit setting) and on child emotion regulation and positive problem solving. Material is delivered in psychoeducational groups in the children's schools.

Peer Group (PG)

Intervention Type: BEHAVIORAL

Peer Group intervention conducted throughout one semester of the school year that includes 12 sessions of a guidance-type curriculum during class time sensitizing children to the importance of social inclusion of all children

Control (n = 82)

Non-intervention control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Family Lifestyle (FL)

12-week Family Food \& Lifestyle intervention, aimed at improving family nutritional intake, activity levels, weight perception, and parental monitoring of child eating. Material is delivered in psychoeducational groups in the children's schools.

Intervention Type: BEHAVIORAL

Family Dynamics (FD)

The Family Dynamics intervention focuses on positive parenting (i.e., emotion coaching, praise, limit setting) and on child emotion regulation and positive problem solving. Material is delivered in psychoeducational groups in the children's schools.

Intervention Type: BEHAVIORAL

Peer Group (PG)

Peer Group intervention conducted throughout one semester of the school year that includes 12 sessions of a guidance-type curriculum during class time sensitizing children to the importance of social inclusion of all children

Intervention Type: BEHAVIORAL

Eligibility Criteria

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%.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amanda Harrist

OTHER

Sponsor Role: lead

Responsible Party

Amanda Harrist

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Amanda W Harrist, PhD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma State University

References

Harrist AW, Swindle TM, Hubbs-Tait L, Topham GL, Shriver LH, Page MC. The Social and Emotional Lives of Overweight, Obese, and Severely Obese Children. Child Dev. 2016 Sep;87(5):1564-80. doi: 10.1111/cdev.12548. Epub 2016 May 25.

Reference Type: BACKGROUND

PMID: 27223340 (View on PubMed)

Shriver LH, Hubbs-Tait L, Harrist AW, Topham G, Page M. Child gender and weight status moderate the relation of maternal feeding practices to body esteem in 1st grade children. Appetite. 2015 Jun;89:62-9. doi: 10.1016/j.appet.2015.01.017. Epub 2015 Jan 23.

Reference Type: BACKGROUND

PMID: 25624022 (View on PubMed)

Harrist AW, Hubbs-Tait L, Topham GL, Shriver LH, Page MC. Emotion regulation is related to children's emotional and external eating. J Dev Behav Pediatr. 2013 Oct;34(8):557-65. doi: 10.1097/DBP.0b013e3182a5095f.

Reference Type: BACKGROUND

PMID: 24131878 (View on PubMed)

Shriver LH, Harrist AW, Page M, Hubbs-Tait L, Moulton M, Topham G. Differences in body esteem by weight status, gender, and physical activity among young elementary school-aged children. Body Image. 2013 Jan;10(1):78-84. doi: 10.1016/j.bodyim.2012.10.005. Epub 2012 Nov 24.

Reference Type: BACKGROUND

PMID: 23228485 (View on PubMed)

Harrist, A. W., Topham, G. L., Hubbs-Tait, L., Page, M. C., Kennedy, T. S., & Shriver, L. H. (2012). What developmental science can contribute to a multidisciplinary understanding of childhood obesity. Child Development Perspectives, 6, 445-465. doi:10.1111/cdep.12004

Reference Type: BACKGROUND

Shriver LH, Harrist AW, Hubbs-Tait L, Topham G, Page M, Barrett A. Weight status, physical activity, and fitness among third-grade rural children. J Sch Health. 2011 Sep;81(9):536-44. doi: 10.1111/j.1746-1561.2011.00624.x.

Reference Type: BACKGROUND

PMID: 21831066 (View on PubMed)

Topham GL, Hubbs-Tait L, Rutledge JM, Page MC, Kennedy TS, Shriver LH, Harrist AW. Parenting styles, parental response to child emotion, and family emotional responsiveness are related to child emotional eating. Appetite. 2011 Apr;56(2):261-4. doi: 10.1016/j.appet.2011.01.007. Epub 2011 Jan 11.

Reference Type: BACKGROUND

PMID: 21232566 (View on PubMed)

Topham GL, Page MC, Hubbs-Tait L, Rutledge JM, Kennedy TS, Shriver L, Harrist AW. Maternal depression and socio-economic status moderate the parenting style/child obesity association. Public Health Nutr. 2010 Aug;13(8):1237-44. doi: 10.1017/S1368980009992163. Epub 2009 Dec 8.

Reference Type: BACKGROUND

PMID: 19968899 (View on PubMed)

Hubbs-Tait L, Kennedy TS, Page MC, Topham GL, Harrist AW. Parental feeding practices predict authoritative, authoritarian, and permissive parenting styles. J Am Diet Assoc. 2008 Jul;108(7):1154-61; discussion 1161-2. doi: 10.1016/j.jada.2008.04.008.

Reference Type: BACKGROUND

PMID: 18589022 (View on PubMed)

Other Identifiers

HR07-044, HR08-043

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NIFA/USDA Agreement No. 05545

Identifier Type: -

Identifier Source: org_study_id