NCT02659319

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
541

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2005

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

5.1 years

First QC Date

January 7, 2016

Last Update Submit

January 14, 2016

Conditions

OverweightPediatric Obesity

Keywords

Child overweightChild obesityFamily dynamicsPeer relationshipsFamily interventionSchool interventionParenting

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (14)

  • 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

  • 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

  • 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

  • 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

  • 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

  • +9 more secondary outcomes

Study Arms (5)

Family Lifestyle (FL; n = 117)

EXPERIMENTAL

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)

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

EXPERIMENTAL

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)Behavioral: Family Dynamics (FD)

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

EXPERIMENTAL

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

Behavioral: Family Lifestyle (FL)Behavioral: Peer Group (PG)

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

EXPERIMENTAL

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

Behavioral: Family Lifestyle (FL)Behavioral: Family Dynamics (FD)Behavioral: Peer Group (PG)

Control (n = 82)

NO INTERVENTION

Non-intervention control group

Interventions

Family Lifestyle (FL)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 + FD + Peer Group (FL+FD+PG; n = 130)FL + Family Dynamics (FL+FD; n = 88)FL + Peer Group (FL+PG; n = 124)Family Lifestyle (FL; n = 117)
Family Dynamics (FD)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 + FD + Peer Group (FL+FD+PG; n = 130)FL + Family Dynamics (FL+FD; n = 88)
Peer Group (PG)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)FL + Peer Group (FL+PG; n = 124)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Children with BMI% greater than or equal to 75% who were enrolled in first grade in participating schools.

You may not qualify if:

  • Children with BMI% \< 75%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 27223340BACKGROUND

  • 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.

    PMID: 25624022BACKGROUND

  • 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.

    PMID: 24131878BACKGROUND

  • 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.

    PMID: 23228485BACKGROUND

  • 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

    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.

    PMID: 21831066BACKGROUND

  • 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.

    PMID: 21232566BACKGROUND

  • 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.

    PMID: 19968899BACKGROUND

  • 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.

    PMID: 18589022BACKGROUND

MeSH Terms

Conditions

OverweightPediatric Obesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsObesity

Study Officials

  • Amanda W Harrist, PhD

    Oklahoma State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 20, 2016

Study Start

May 1, 2005

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

January 20, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share