Families and Schools for Health

Overweight Clinical Trial

— FiSH  

Official title:

Intervening in Family and Peer Contexts to Decrease Child Overweight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02659319
• Other study ID #: NIFA/USDA Agreement No. 05545
• Secondary ID: HR07-044, HR08-0
• Status: Completed
• Phase: N/A
• First received: January 7, 2016
• Last updated: January 14, 2016
• Start date: May 2005
• Est. completion date: June 2010

Study information

• Verified date: January 2016
• Source: Oklahoma State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 541
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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%.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Overweight
• Pediatric Obesity

Intervention

Behavioral:
• 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.
• 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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amanda Harrist

References & Publications (10)

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. — View Citation

Harrist, A. W., Swindle, T. M., Hubbs-Tait, L., Topham, G. L., Page, M. C., & Shriver, L. H. (in press). The social and emotional lives of overweight, obese, and severely obese children. Manuscript accepted for publication, Child Development.

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

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. — View Citation

Hubbs-Tait, L., Kennedy, T. S., Page, M. C., Topham, G. L., & Harrist, A. W. (2008). Parenting practice and nutrition practice. Journal of the American Dietetic Association, 108, 1161-1162. doi:10.1016/j.jada.2008.04.010

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Change from Baseline to End of 1st grade	Height and weight measured at Wave 2 (Spring 1st grade), vs. Baseline at Fall 1st grade	Wave 2, Spring Year 1	No
Primary	Body Mass Change from Baseline to End of 2nd grade	Height and weight measured at Wave 3 (Spring 2nd grade), vs. Baseline at Wave 1, Fall 1st grade	Wave 3, Spring Year 2
Primary	Body Mass Change from Baseline to End of 3rd grade	Height and weight measured at Wave 4 (Spring 3rd grade), vs. Baseline at Wave 1, Fall 1st grade	Wave 4, Spring Year 3
Primary	Body Mass Change from Baseline to End of 4th grade	Height and weight measured at Wave 5 (Spring 4th grade) vs. Baseline at Wave 1, Fall 1st grade	Wave 5, Spring Year 4
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No