Clinical trial NCT02659319: Families and Schools for Health
Official title: Intervening in Family and Peer Contexts to Decrease Child Overweight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Pediatric Obesity
Keywords: Child overweight
Child obesity
Family dynamics
Peer relationships
Family intervention
School intervention
Parenting
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 541
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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%.

Primary outcomes:
measure: Body Mass Change from Baseline to End of 1st grade
timeFrame: Wave 2, Spring Year 1
measure: Body Mass Change from Baseline to End of 2nd grade
timeFrame: Wave 3, Spring Year 2
measure: Body Mass Change from Baseline to End of 3rd grade
timeFrame: Wave 4, Spring Year 3
measure: Body Mass Change from Baseline to End of 4th grade
timeFrame: Wave 5, Spring Year 4
Secondary outcomes:
measure: Parent perceived responsibility, weight, child weight, concerns about weight, feeding practices - parent report
timeFrame: 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
measure: Parent expectations about, parent modeling of, and parent perception of child beliefs regarding eating - parent report
timeFrame: 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
measure: Family problem solving, communication, affective responsiveness, affective involvement, & general family functioning - parent report
timeFrame: 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
measure: Parenting style (permissive, authoritative, authoritarian) - parent report
timeFrame: 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
measure: Parent response to child negative emotions - parent report
timeFrame: 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
measure: Child temperament - child and parent report
timeFrame: Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
measure: Child emotion management - Parent and child report
timeFrame: Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4
measure: Child behavior problems - Parent and teacher report (externalizing, internalizing)
timeFrame: 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
measure: School climate
timeFrame: 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
measure: Peer relations - child, peer, and teacher reports
timeFrame: 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
measure: Child emotional and external eating - child self report
timeFrame: 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
measure: Body esteem - child self report
timeFrame: 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
measure: Child self esteem - child self report
timeFrame: 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
measure: Child depressive symptoms - child self report
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Oklahoma State University
name: Amanda W Harrist, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.
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.
citation: 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
citation: 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.
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.
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.
citation: 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.