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Church, Extension and Academic Partners Empowering Healthy Families (EHF)

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ClinicalTrials.gov Identifier: NCT03980262
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborators:
Virginia State University
Baptist General Convention of Virginia
Virginia Cooperative Extension
Virginia Family Nutrition Program
Virginia Tech Center for Public Health Practice and Research
Information provided by (Responsible Party):
Kathryn W. Hosig, Virginia Polytechnic Institute and State University

Brief Summary:
The project will address health disparities via a community-engaged approach in partnership with black churches. The long-term goals of this integrated project are to: 1) prevent and reduce childhood obesity through improved parenting practices and home environment related to obesity; 2) expand Extension capacity for community-engaged research and collaborative programming with faith-based organizations; 3) enhance Extension strategies for recruiting and training community volunteers to extend Extension reach; and 4) train future health professionals to provide culturally appropriate collaborative community-based health programs. The project will target the school-aged subset (ages 6-11, first through fifth grade) of the USDA target age range of ages 2-19. The 14-month randomized control trial design of the research component will generate new knowledge regarding effectiveness of a integrated family-based intervention enhanced with social and environmental (church) support to prevent obesity in school-aged children. The research design with a financial literacy active control condition and the primary nutrition and physical activity intervention being tested meets two needs expressed by the community partner and allows rigorous evaluation of both Extension programs. It is hypothesized that parents in the intervention group will have higher levels of self-efficacy for obesity-prevention behaviors, parenting practices related to food and physical activity, improved home food and physical activity. The long term impact is to reduce the prevalence of childhood obesity.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Healthy Children, Healthy Families+ (HCHF+) Behavioral: Money Smart Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Twenty-four churches will participate and each church will be randomly assigned to treatment or control condition. 1) treatment: lifestyle and parenting intervention for parents with a complementary age-appropriate lifestyle curriculum for children and strategies to improve the church health environment (HCHF+); or 2) active control: financial literacy curricula (Money Smart) for parents and children. Churches will receive the alternate program after 12-month data collection for their initial program. This is for community-engaged approach and will also facilitate program evaluation for both the intervention and comparator conditions.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Church, Extension and Academic Partners Empowering Healthy Families
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : February 28, 2024
Estimated Study Completion Date : February 28, 2024

Arm Intervention/treatment
Experimental: Healthy Children, Healthy Families+ (HCHF+)
HCHF+ integrates healthful eating and physical activity with parenting education (parent role modeling and child feeding practices) and was recently shown to improve parent and child nutrition behaviors for participants in the Expanded Food and Nutrition Education (EFNEP) program. OrganWise Guys (OWG) will be used for children in first and second grades (ages 6-8). Choose Health: Food, Fun and Fitness (CHFF), developed by Cornell University, will be used for children in grades three through five (ages 8-10). HCHF+ includes 9 sessions to be delivered weekly.
Behavioral: Healthy Children, Healthy Families+ (HCHF+)
HCHF+ integrates healthful eating and physical activity with parenting education (parent role modeling and child feeding practices) and was recently shown to improve parent and child nutrition behaviors for participants in the Expanded Food and Nutrition Education (EFNEP) program. OrganWise Guys (OWG) will be used for children in first and second grades (ages 6-8). Choose Health: Food, Fun and Fitness (CHFF), developed by Cornell University, will be used for children in grades three through five (ages 8-10). HCHF+ includes 9 sessions to be delivered weekly.

Active Comparator: MoneySmart
A financial education program available through the Federal Deposit Insurance Corporation. Money Smart includes programs for adults and school-aged children, a parent/caregiver guide and a train-the-trainer program. MoneySmart is an Extension-approved program designed to improve money-management practices and financial confidence for parents MoneySmart involves eight weekly sessions that includes one-to-two hour modules with take-home guides for adults. For children, there are eight sessions that include take-home worksheets and a parent/caregiver guide.
Behavioral: Money Smart
Money Smart is a financial literacy education program developed by the Federal Deposit Insurance Corporation (FDIC). Curricula are available for both adults and children.




Primary Outcome Measures :
  1. Change in Parental self-efficacy at 6- and 12-months: Self-efficacy for Obesity Prevention Related Behaviors instrument [ Time Frame: Baseline, 6-months, 12-months ]
    Change in parental self-efficacy is measured over time with the 16 item Self-efficacy for Obesity Prevention Related Behaviors Instrument comprised of four validated subscales to assess parent's self-efficacy to help their child get recommended physical activity and fruits and vegetables, and to limit sugary drinks and fruit juice. Specifically, the four subscales are: physical activity (4 items), fruits and vegetables (4 items), sugary drinks (4 items), and fruit juice (4 items). Response options are: not sure, a little sure, sure, very sure, and extremely sure. Scores are summed for each subscale. Scores range from 4 to 20, with higher scores indicating greater self-efficacy (i.e. better outcome).

  2. Change in Child self-efficacy at 6- and 12-months: 3-item response scale [ Time Frame: Baseline, 6-months, 12-months ]
    Change in child self-efficacy is measured over time using procedures validated with 5-10 year old children where pictures of healthy food and physical activity choices are paired with a 3-item response scale: (1) they could not make the healthful choices, (2) they could make the healthful choices sometimes, or (3) they could make the healthful choices all the time. Scores can either be summed or averaged with higher scores indicating greater self-efficacy to make healthful choices (i.e. better outcome).

  3. Change in parental feeding practices/self-regulatory behaviors at 6- and 12-months [ Time Frame: Baseline, 6-months, 12-months ]
    Change in parental feeding practices/self-regulatory behaviors is measured over time using the 31 item Child Feeding Questionnaire uses a 5-point Likert-type scales with responses across seven factor-based domains: perceived responsibility (3 items), perceived parent weight (4 items), perceived child weight (3 items), concern about child weight (3 items), restriction (8 items), pressure to eat (4 items), and monitoring (3 items). Response options vary for each subscale. Means are calculated for each domain. Scores range from 1 to 5 with higher scores indicating higher levels of each domain.

  4. Change in parental supportive behaviors for children's physical activity at 6- and 12-months [ Time Frame: Baseline, 6-months, 12-months ]
    Change in supportive behaviors by parents to enable child physical activity is measured over time with 8 items from the Activity Support Scale (ASS). A 4-point response scale measures parent support for children's physical activity, family co-participation in physical activity, and parent encouragement of child outdoor play. Response options are the following: strongly disagree, disagree, agree, strongly agree.The scale has been shown to be sensitive to change related to a community-based intervention in a similar population as is targeted in the study. The mean is calculated, with possible scores ranging from 1 to 4. Higher scores indicate greater levels of support for physical activity (i.e. better outcome)

  5. Change in home food and physical activity environment at 6- and 12-months [ Time Frame: Baseline, 6-months, 12-months ]
    Change in home food and physical activity environment is measured over time with the Healthy Children, Healthy Families Behavior Checklist (HCHF-BC) developed for use with low-income parents of 3- to 11-year old children. The checklist has demonstrated good reliability (test-retest r=0.83) and convergent validity (scores significantly correlated with validated measures of diet, parent modeling, physical activity and home environment). Six subscales measured are the following: fruits and vegetables, low-fat dairy foods, soda, energy-dense foods, physical activity, and parenting practices. Response options for each item vary. For each individual item, higher values indicate higher frequency of the corresponding behavior. Authors of the instrument recommended computing mean across the items so that higher scores reflect more healthful practices - for this, behaviors or foods that reduced frequency is recommended, the checklist item should be reverse coded in the mean score.


Secondary Outcome Measures :
  1. Change in parent nutrition behaviors at 6- and 12-months [ Time Frame: Baseline, 6-months, 12-months ]
    Change in parent nutrition behaviors is measured over time with the validated Block Alive Fat-Sugar-Fruit Vegetable Screener which includes 55 questions and takes about 10-12 minutes. There are two subscales: meat/snacks and fruits/vegetables. For meat and snacks, response options are the following: Once per month or less, 2-3 times per month, 1-2 times per week, 3-4 times per week, and 5 or more times per week. Scores are summed and range from 0 to 60, with higher scores representing greater meat/snack intake. For fruits and vegetables, response options are the following: less than once per week, about once per week, 2-3 times per week, 4-6 times per week, every day, 2 or more times per day. Scores are summed and range from 0 to 35, with higher scores representing greater fruit/vegetable intake.

  2. Change in parent physical activity at 6- and 12-months [ Time Frame: Baseline, 6-months, 12-months ]
    Change in parent physical activity is measured over time with the Godin Leisure-Time Exercise Questionnaire. Weekly frequencies of strenuous, moderate, and mild activities are multiplied by nine, five, and three metabolic equivalents, respectively, and summed to form a measure of total leisure activity. Interpretation of the scoring is the following: 24 unites or more = Active, 14 - 23 = moderately active, Less than 14 unites = insufficiently Active/Sedentary.

  3. Change in child nutrition at 6- and 12-months [ Time Frame: Baseline, 6-months, 12-months ]
    Change in child nutrition is measured over time using the After School Student Questionnaire (ASSQ), which includes questions about child food choices. Constructs measured include: dietary intake for the previous day (6 items), healthy dietary behaviors (6 items), food knowledge (10 items), nutrition knowledge (3 items), food intentions (8 items), and dietary self-efficacy (8 items). Response options vary for each item. For knowledge items, the percentage of correct responses are summed. Higher scores indicated greater knowledge (i.e. better outcome). For behavior and self-efficacy, mean or sum scores are calculated with higher scores indicating higher behavior frequency and high self-efficacy (i.e. better outcome)

  4. Change in child sedentary behavior and physical activity at 6- and 12-months [ Time Frame: Baseline, 6-months, 12-months ]
    Change in child sedentary behavior and physical activity is measured over time using the After School Student Questionnaire (ASSQ), which includes questions about mild and moderate levels of physical activity and physical activity self-regulation. Specific subscales include: physical activity self-efficacy (4 items), participation in sports activities (2 items), and participation in sedentary activities (4 items). For physical activity subscales, sum scores are calculated with higher scores indicating higher frequency of the behavior and self-efficacy (i.e. better outcome). For sedentary behavior, sum scores are calculated with higher scores indicating higher sedentary behavior (i.e. worse outcome)

  5. Change in Child and Parent Body Mass Index (BMI) at 6- and 12-months [ Time Frame: Baseline, 6-months, 12-months ]
    Change in Child and Parent Body Mass Index (BMI) is measured over time without shoes to the nearest ¼ inch using a portable stadiometer. Weight will be measured in light clothing without shoes to the nearest 0.2 pound using a portable digital scale. BMI z-score is recommended for child obesity prevention research. BMI will be calculated from measured height and weight (kg/M2). The better outcome would to see a decrease in BMI for those overweight or obese.



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • a parent or primary caregiver and child (age 6-10) dyad living in the same household
  • English-speaking

Exclusion Criteria:

  • Parent does not have a child between the ages of 6 and 11
  • Target child does not live or spend significant time with parent/caregiver
  • non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980262


Contacts
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Contact: Kathryn W Hosig, PhD, MPH 540-231-6637 khosig@vt.edu
Contact: Jyoti Savla, PhD 540-231-2348 jsavla@vt.edu

Locations
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United States, Virginia
Baptist General Convention of Virginia Recruiting
Richmond, Virginia, United States, 23220
Contact: Elisha Burke, PhD    804-228-2421    bgcdom@yahoo.com   
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
Virginia State University
Baptist General Convention of Virginia
Virginia Cooperative Extension
Virginia Family Nutrition Program
Virginia Tech Center for Public Health Practice and Research
Publications:
Creswell JW. Qualitative inquiry & research design: Choosing among five approaches (2nd ed). SAGE: Thousand Oaks, CA. 2007
Strauss A. Qualitative analysis for social scientists. Cambridge University Press: Cambridge, England. 1987
Raykov T. Analysis of longitudinal studies with missing data using covariance structure modeling with full-information maximum likelihood. Structural Equation Modeling.12: 493-505. 2005

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Responsible Party: Kathryn W. Hosig, Associate Professor, Department of Population Health Sciences & Director, Center for Public Health Practice and Research, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT03980262    
Other Study ID Numbers: 2017-07071
2018-68001-27549 ( Other Grant/Funding Number: United States Department of Agriculture (NIFA) )
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kathryn W. Hosig, Virginia Polytechnic Institute and State University:
Obesity
Self-efficacy
Nutrition
Physical Activity
Family-based
Community-Based Participatory Research (CBPR)
Faith-based organizations
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight