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Completed

NCT Number: NCT00998348

Study of Parenting Intervention to Prevent Child Obesity

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parenting Program

Behavioral

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 names: Parenting SOS

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.

    Time frame: baseline, 8 months and 14 months

Secondary outcomes

  1. 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

  2. Parent BMI based on measured height and weight

    Time frame: baseline, 8 months and 14 months

  3. 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

  4. 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

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

    Time frame: baseline, 8 months and 14 months

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. The Parenting Convergence Scale (Ahrons, 1981) will be used to assess parental skill with coparenting

    Time frame: baseline, 8 months and 14 months

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Healthy Child Weight Through Improved Parent Practices and Environmental Change

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Oct 20, 2009
Registry last updated
Jun 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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