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Families and Schools for Health (FiSH)

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ClinicalTrials.gov Identifier: NCT02659319
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Amanda Harrist, Oklahoma State University

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.

Condition or disease Intervention/treatment Phase
Overweight Pediatric Obesity Behavioral: Family Lifestyle (FL) Behavioral: Family Dynamics (FD) Behavioral: Peer Group (PG) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 541 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intervening in Family and Peer Contexts to Decrease Child Overweight
Study Start Date : May 2005
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Experimental: 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.
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.

Experimental: 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.
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.

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.

Experimental: FL + Peer Group (FL+PG; n = 124)
This arm includes the Family Food & Lifestyle intervention plus the 12-session, Peer Group 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.

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

Experimental: 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.
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.

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.

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

No Intervention: Control (n = 82)
Non-intervention control group



Primary Outcome Measures :
  1. Body Mass Change from Baseline to End of 1st grade [ Time Frame: Wave 2, Spring Year 1 ]
    Height and weight measured at Wave 2 (Spring 1st grade), vs. Baseline at Fall 1st grade

  2. Body Mass Change from Baseline to End of 2nd grade [ Time Frame: Wave 3, Spring Year 2 ]
    Height and weight measured at Wave 3 (Spring 2nd grade), vs. Baseline at Wave 1, Fall 1st grade

  3. Body Mass Change from Baseline to End of 3rd grade [ Time Frame: Wave 4, Spring Year 3 ]
    Height and weight measured at Wave 4 (Spring 3rd grade), vs. Baseline at Wave 1, Fall 1st grade

  4. Body Mass Change from Baseline to End of 4th grade [ Time Frame: 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 :
  1. Parent perceived responsibility, weight, child weight, concerns about weight, feeding practices - parent report [ Time Frame: 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 ]
  2. Parent expectations about, parent modeling of, and parent perception of child beliefs regarding eating - parent report [ Time Frame: 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 ]
  3. Family problem solving, communication, affective responsiveness, affective involvement, & general family functioning - parent report [ Time Frame: 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 ]
  4. Parenting style (permissive, authoritative, authoritarian) - parent report [ Time Frame: 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 ]
  5. Parent response to child negative emotions - parent report [ Time Frame: 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 ]
  6. Child temperament - child and parent report [ Time Frame: Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4 ]
  7. Child emotion management - Parent and child report [ Time Frame: Wave 2 Spring year 1, Wave 3 Spring year 2, Wave 4 Spring year 3, Wave 5 Spring year 4 ]
  8. Child behavior problems - Parent and teacher report (externalizing, internalizing) [ Time Frame: 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 ]
  9. School climate [ Time Frame: 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 ]
  10. Peer relations - child, peer, and teacher reports [ Time Frame: 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 ]
  11. Child emotional and external eating - child self report [ Time Frame: 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 ]
  12. Body esteem - child self report [ Time Frame: 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 ]
  13. Child self esteem - child self report [ Time Frame: 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 ]
  14. Child depressive symptoms - child self report [ Time Frame: 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659319


Sponsors and Collaborators
Amanda Harrist
Investigators
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Principal Investigator: Amanda W Harrist, PhD Oklahoma State University
Publications:
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, 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

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Responsible Party: Amanda Harrist, Professor, Oklahoma State University
ClinicalTrials.gov Identifier: NCT02659319    
Other Study ID Numbers: NIFA/USDA Agreement No. 05545
HR07-044, HR08-043 ( Other Grant/Funding Number: Oklahoma Health Research Program )
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Amanda Harrist, Oklahoma State University:
Child overweight
Child obesity
Family dynamics
Peer relationships
Family intervention
School intervention
Parenting
Additional relevant MeSH terms:
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Pediatric Obesity
Overweight
Obesity
Overnutrition
Nutrition Disorders
Body Weight