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Families and Schools for Health (FiSH)

Primary Purpose

Overweight, Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Family Lifestyle (FL)
Family Dynamics (FD)
Peer Group (PG)
Sponsored by
Amanda Harrist
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Child overweight, Child obesity, Family dynamics, Peer relationships, Family intervention, School intervention, Parenting

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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%.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    Family Lifestyle (FL; n = 117)

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

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

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

    Control (n = 82)

    Arm 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.

    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.

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

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

    Non-intervention control group

    Outcomes

    Primary Outcome Measures

    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
    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
    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
    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

    Secondary Outcome Measures

    Parent perceived responsibility, weight, child weight, concerns about weight, feeding practices - parent report
    Parent expectations about, parent modeling of, and parent perception of child beliefs regarding eating - parent report
    Family problem solving, communication, affective responsiveness, affective involvement, & general family functioning - parent report
    Parenting style (permissive, authoritative, authoritarian) - parent report
    Parent response to child negative emotions - parent report
    Child temperament - child and parent report
    Child emotion management - Parent and child report
    Child behavior problems - Parent and teacher report (externalizing, internalizing)
    School climate
    Peer relations - child, peer, and teacher reports
    Child emotional and external eating - child self report
    Body esteem - child self report
    Child self esteem - child self report
    Child depressive symptoms - child self report

    Full Information

    First Posted
    January 7, 2016
    Last Updated
    January 14, 2016
    Sponsor
    Amanda Harrist
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02659319
    Brief Title
    Families and Schools for Health
    Acronym
    FiSH
    Official Title
    Intervening in Family and Peer Contexts to Decrease Child Overweight
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2005 (undefined)
    Primary Completion Date
    June 2010 (Actual)
    Study Completion Date
    June 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Amanda Harrist

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight, Pediatric Obesity
    Keywords
    Child overweight, Child obesity, Family dynamics, Peer relationships, Family intervention, School intervention, Parenting

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    541 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Family Lifestyle (FL; n = 117)
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    FL + Family Dynamics (FL+FD; n = 88)
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    FL + Peer Group (FL+PG; n = 124)
    Arm Type
    Experimental
    Arm Description
    This arm includes the Family Food & Lifestyle intervention plus the 12-session, Peer Group intervention.
    Arm Title
    FL + FD + Peer Group (FL+FD+PG; n = 130)
    Arm Type
    Experimental
    Arm Description
    This arm includes the Family Food & Lifestyle intervention plus the Family Dynamics Intervention plus the Peer Group intervention.
    Arm Title
    Control (n = 82)
    Arm Type
    No Intervention
    Arm Description
    Non-intervention control group
    Intervention Type
    Behavioral
    Intervention Name(s)
    Family Lifestyle (FL)
    Intervention Description
    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
    Intervention Name(s)
    Family Dynamics (FD)
    Intervention Description
    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
    Intervention Name(s)
    Peer Group (PG)
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Body Mass Change from Baseline to End of 1st grade
    Description
    Height and weight measured at Wave 2 (Spring 1st grade), vs. Baseline at Fall 1st grade
    Time Frame
    Wave 2, Spring Year 1
    Title
    Body Mass Change from Baseline to End of 2nd grade
    Description
    Height and weight measured at Wave 3 (Spring 2nd grade), vs. Baseline at Wave 1, Fall 1st grade
    Time Frame
    Wave 3, Spring Year 2
    Title
    Body Mass Change from Baseline to End of 3rd grade
    Description
    Height and weight measured at Wave 4 (Spring 3rd grade), vs. Baseline at Wave 1, Fall 1st grade
    Time Frame
    Wave 4, Spring Year 3
    Title
    Body Mass Change from Baseline to End of 4th grade
    Description
    Height and weight measured at Wave 5 (Spring 4th grade) vs. Baseline at Wave 1, Fall 1st grade
    Time Frame
    Wave 5, Spring Year 4
    Secondary Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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%.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amanda W Harrist, PhD
    Organizational Affiliation
    Oklahoma State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27223340
    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.
    Results Reference
    background
    PubMed Identifier
    25624022
    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.
    Results Reference
    background
    PubMed Identifier
    24131878
    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.
    Results Reference
    background
    PubMed Identifier
    23228485
    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.
    Results Reference
    background
    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
    Results Reference
    background
    PubMed Identifier
    21831066
    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.
    Results Reference
    background
    PubMed Identifier
    21232566
    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.
    Results Reference
    background
    PubMed Identifier
    19968899
    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.
    Results Reference
    background
    PubMed Identifier
    18589022
    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.
    Results Reference
    background

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