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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00998348 |
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Date of registration:
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16/10/2009 |
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Primary sponsor: |
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Public title:
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Study of Parenting Intervention to Prevent Child Obesity
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Scientific title:
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Healthy Child Weight Through Improved Parent Practices and Environmental Change |
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Date of first enrolment:
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July 2009 |
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Target sample size:
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280 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00998348 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Dianne S Ward, EdD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of North Carolina, Chapel Hill |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Behavioral: Parenting Program
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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Parent BMI based on measured height and weight
[Time Frame: baseline, 8 months and 14 months]
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Parenting-related stress assessed with the Parental Stress Index - Short Form (Abidin, 1995)
[Time Frame: baseline, 8 months and 14 months]
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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]
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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]
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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]
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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]
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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]
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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]
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The Parenting Convergence Scale (Ahrons, 1981) will be used to assess parental skill with coparenting
[Time Frame: baseline, 8 months and 14 months]
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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]
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Secondary ID(s)
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08-0354
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1R01HL091093-01A1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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