NCT00998348

Brief Summary

This purpose of this project is to determine whether this 8-month parenting for healthy weight intervention is able to help parents improve their parenting skills and make positive changes in the nutrition and physical activity environment at home.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
324

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

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

July 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 17, 2013

Status Verified

June 1, 2013

Enrollment Period

2.4 years

First QC Date

October 16, 2009

Last Update Submit

June 13, 2013

Conditions

Keywords

parentingdietphysical activityfamilyhomechild

Outcome Measures

Primary Outcomes (1)

  • Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds.

    baseline, 8 months and 14 months

Secondary Outcomes (20)

  • Child BMI and Child BMI z-score based on measured child height, weight, and parent-reported date of birth

    baseline, 8 months and 14 months

  • Parent BMI based on measured height and weight

    baseline, 8 months and 14 months

  • Parent and child dietary intake measured with 3 unannounced dietary recalls collected via telephone interview (will not include foods eaten by child while outside of parent's care)

    baseline, 8 months and 14 months

  • Parent and child physical activities assessed via 7-days of accelerometer monitoring (using the AciGraph GT3X monitor programed with 60-s epochs for adults and 15-s epochs for children)

    baseline, 8 months and 14 months

  • Parenting-related stress assessed with the Parental Stress Index - Short Form (Abidin, 1995)

    baseline, 8 months and 14 months

  • +15 more secondary outcomes

Study Arms (2)

Comparison Group

NO INTERVENTION

The comparison group will receive children's picture books (1 per month for the duration of the 8-month program).

Parenting Program

EXPERIMENTAL

The parenting program is an 8-month obesity prevention intervention for parents with preschool-age children.

Behavioral: Parenting Program

Interventions

The parenting program is an 8-month intervention for parents with preschool-age children designed to teach strategies and skills that help parents better manage their day to day stresses of parenting while also promoting healthy lifestyle behaviors. Topics will include stress management, child management, family routines, emotion regulation, and coparenting. In later sessions parents will be encouraged to draw on these general parenting skills to promote healthier nutrition and physical practices at home. The intervention will be delivered through in-person group sessions (n=12) and tailored one-on-one telephone calls (n=11). A complementary child program will be delivered to children while parents are attending the group sessions.

Also known as: Parenting SOS
Parenting Program

Eligibility Criteria

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

You may qualify if:

  • Families must have at least one child age 2-5 years. The scientific rationale for focusing on this young population is that this age range includes the period often referred to as the "adiposity rebound," which has been identified as one of the critical periods for obesity development. Additionally, children of this age are still subject to strong parent and family influences which may be amenable to intervention.
  • At least one parent or caregiver in the household must be overweight (BMI ≥25); however, this does not have to be the participating parent. The scientific rationale for focusing on families with at least one overweight parent is that having an overweight parent increases the child's risk of becoming overweight.
  • Parents must be willing to participate in measures and intervention activities, and give consent for child's and his/her own participation.

You may not qualify if:

  • Parents who are unable to speak English or comprehend standard age-level materials will be excluded. Currently funds are not available to translate and provide the program in Spanish or other languages.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7426, United States

Location

Related Publications (1)

  • Ward DS, Vaughn AE, Bangdiwala KI, Campbell M, Jones DJ, Panter AT, Stevens J. Integrating a family-focused approach into child obesity prevention: rationale and design for the My Parenting SOS study randomized control trial. BMC Public Health. 2011 Jun 5;11:431. doi: 10.1186/1471-2458-11-431.

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Dianne S Ward, EdD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 16, 2009

First Posted

October 20, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

June 17, 2013

Record last verified: 2013-06

Locations