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Study of Parenting Intervention to Prevent Child Obesity

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ClinicalTrials.gov Identifier: NCT00998348
Recruitment Status : Completed
First Posted : October 20, 2009
Last Update Posted : June 17, 2013
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Dianne S. Ward, University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE October 16, 2009
First Posted Date  ICMJE October 20, 2009
Last Update Posted Date June 17, 2013
Study Start Date  ICMJE July 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2009)
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. [ Time Frame: baseline, 8 months and 14 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2009)
  • Child BMI and Child BMI z-score based on measured child height, weight, and parent-reported date of birth [ Time Frame: baseline, 8 months and 14 months ]
  • Parent BMI based on measured height and weight [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: baseline, 8 months and 14 months ]
  • Parenting-related stress assessed with the Parental Stress Index - Short Form (Abidin, 1995) [ Time Frame: baseline, 8 months and 14 months ]
  • Autonomous motivation to change behaviors (parenting practices, feeding practices, and physical activity practices) will be assessed using modified versions of the Treatment Self-Regulation Questionnaire (Williams GC, 1996) [ Time Frame: baseline, 8 months and 14 months ]
  • Self-efficacy for general parenting will be assessed with the Parenting Sense of Competence Scale (Johnston C, 1989) [ Time Frame: baseline, 8 months and 14 months ]
  • Self-efficacy for implementing healthy nutrition and physical activity practices will be assessed with an instrument recently developed by the PI. [ Time Frame: baseline, 8 months and 14 months ]
  • Parents' perceived social support and connectedness with regard to positive parenting and healthy feeding and physical activity practices will be assessed using modified versions of the Social Provisions Scale (Cutrona, 1987) [ Time Frame: baseline, 8 months and 14 months ]
  • The Alabama Parenting Questionnaire - Preschool Revision (Clerkin, 2007)will be used to assess general parenting practices, specifically the use of positive parenting, inconsistent parenting, and punitive parenting [ Time Frame: baseline, 8 months and 14 months ]
  • Difficulties in Emotion Regulation (Gratz, 2004) will be used to assess parental skills at regulating their own emotions [ Time Frame: baseline, 8 months and 14 months ]
  • Coping with Children's Negative Emotions (Fabes, 1990) will be used to assess parental skill at helping the child deal with and manage his/her negative emotions [ Time Frame: baseline, 8 months and 14 months ]
  • Confusion, Hubbub, and Order Scale (Matheny, 1995) will be used to assess the degree of order versus confusion in the home environment [ Time Frame: baseline, 8 months and 14 months ]
  • The Parenting Convergence Scale (Ahrons, 1981) will be used to assess parental skill with coparenting [ Time Frame: baseline, 8 months and 14 months ]
  • The Caregiver Feeding Style Questionnaire (Hughes SO, 2005) will be used to assess the two dimensions of parenting: demandingness and responsiveness as they relate to feeding practices [ Time Frame: baseline, 8 months and 14 months ]
  • The Parental Feeding Style Questionnaire (Wardle, 2002) will be used to assess parents' use of emotional feeding, instrumental feeding, encouraging to eat, and control over eating [ Time Frame: baseline, 8 months and 14 months ]
  • Nine subscales from the Comprehensive Feeding Practices Questionnaire (Musher-Eizenman, 2007) will be used to assess child control, encouraging balance/variety, involvement, modeling, monitoring, pressure to eat, restriction for health or weight control, [ Time Frame: baseline, 8 months and 14 months ]
  • One sub-scale from the Preschooler Feeding Questionnaire (Baughcum, 2001) will be used to assess structure during feeding interactions [ Time Frame: baseline, 8 months and 14 months ]
  • Two items slightly modified from the Child Feeding Questionnaire (Birch, 2001) will be used to determine parent perceptions of child weight and concern about child becoming overweight [ Time Frame: baseline, 8 months and 14 months ]
  • A variety of newly developed items drawn from the literature will be used to assess parent practices around child physical activity [ Time Frame: baseline, 8 months and 14 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Parenting Intervention to Prevent Child Obesity
Official Title  ICMJE Healthy Child Weight Through Improved Parent Practices and Environmental Change
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.
Detailed Description The early years between ages 3-7 are critical in the development of obesity. The importance of the family in the development of children's eating and activity behaviors has been emphasized by experts, yet to date no obesity prevention interventions incorporating a strong family focus with emphasis on improved parenting practices have been developed. The work proposed here will address this gap by testing the efficacy of an 8-mo parenting intervention designed to change both social and physical aspects of the home environment, which in turn will reduced % body fat in children. Subjects will be 280 families (one parent and one child from each) with at least one preschool-age child (2-5 years old). Following baseline measures, pairs will be randomized into intervention or control. The intervention will teach more effective parenting skills (child management, communication, routines, etc.), then apply these skills to specific practices that encourage healthier behaviors. The intervention will include group sessions and tailored phone calls facilitated by a registered dietitian who has also received training in parent education. Group sessions will use multiple teaching strategies and include separate child activities. Tailored calls will use motivational interviewing techniques to help parents overcome barriers to behavior change. The intervention is guided by Darling and Steinberg's Integrative Model of parenting, which highlights the importance of parenting values, style and practices in child socialization, and Deci and Ryan's Self-Determination Theory, which suggests ways to foster autonomous motivation to adopt new behaviors. The resulting intervention will help parents learn skills to reduce their parenting-related stress and create home environments that support healthy-weight behaviors. The primary outcome, % body fat in children, will be assessed using anthropometry and a validated prediction equation (Dezenberg, 1999). Analyses will include baseline measurements of the outcome as a covariate. Secondary measures include child and parent diet and physical activity, parenting style and practices, and home environment. Maintenance effect will be assessed following a 6-mo no-intervention period. A comprehensive analysis is included to test for mediation effects. This intensive intervention will create the exposure necessary to make life-altering changes in weight-related behaviors. Plans build on extensive formative work conducted by our experienced researchers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE Behavioral: Parenting Program
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.
Other Name: Parenting SOS
Study Arms  ICMJE
  • No Intervention: Comparison Group
    The comparison group will receive children's picture books (1 per month for the duration of the 8-month program).
  • Experimental: Parenting Program
    The parenting program is an 8-month obesity prevention intervention for parents with preschool-age children.
    Intervention: Behavioral: Parenting Program
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2013)
324
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2009)
280
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00998348
Other Study ID Numbers  ICMJE 08-0354
1R01HL091093-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dianne S. Ward, University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Dianne S Ward, EdD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP