Church, Extension and Academic Partners Empowering Healthy Families

NCT03980262 | Terminated

• 2 other identifiers: 2017-070712018-68001-27549
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Self-efficacy; Nutrition; Physical Activity; Family-based; Community-Based Participatory Research (CBPR); Faith-based organizations

Outcome Measures

Primary Outcomes (5)

• Change in Parental self-efficacy at 6- and 12-months: Self-efficacy for Obesity Prevention Related Behaviors instrument

  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).

  Baseline, 6-months, 12-months

• Change in Child self-efficacy at 6- and 12-months: 3-item response scale

  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).

  Baseline, 6-months, 12-months

• Change in parental feeding practices/self-regulatory behaviors at 6- and 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.

  Baseline, 6-months, 12-months

• Change in parental supportive behaviors for children's physical activity at 6- and 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)

  Baseline, 6-months, 12-months

• Change in home food and physical activity environment at 6- and 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.

  Baseline, 6-months, 12-months

Secondary Outcomes (5)

• Change in parent nutrition behaviors at 6- and 12-months

  Baseline, 6-months, 12-months

• Change in parent physical activity at 6- and 12-months

  Baseline, 6-months, 12-months

• Change in child nutrition at 6- and 12-months

  Baseline, 6-months, 12-months

• Change in child sedentary behavior and physical activity at 6- and 12-months

  Baseline, 6-months, 12-months

• Change in Child and Parent Body Mass Index (BMI) at 6- and 12-months

  Baseline, 6-months, 12-months

Study Arms (2)

Healthy Children, Healthy Families+ (HCHF+)

EXPERIMENTAL

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+)

MoneySmart

ACTIVE COMPARATOR

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

Interventions

Healthy Children, Healthy Families+ (HCHF+) BEHAVIORAL

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.

Healthy Children, Healthy Families+ (HCHF+)

Money Smart BEHAVIORAL

Money Smart is a financial literacy education program developed by the Federal Deposit Insurance Corporation (FDIC). Curricula are available for both adults and children.

MoneySmart

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• Baptist General Convention of Virginia: collaborator
• Virginia Cooperative Extension: collaborator
• Virginia Family Nutrition Program: collaborator
• Virginia Tech Center for Public Health Practice and Research: collaborator

Study Sites (1)

Baptist General Convention of Virginia

Richmond, Virginia, 23220, United States

Location

Related Publications (16)

• Wright JA, Adams WG, Laforge RG, Berry D, Friedman RH. Assessing parental self-efficacy for obesity prevention related behaviors. Int J Behav Nutr Phys Act. 2014 Apr 22;11:53. doi: 10.1186/1479-5868-11-53.

  PMID: 24750693 BACKGROUND

• Edmundson E, Parcel GS, Feldman HA, Elder J, Perry CL, Johnson CC, Williston BJ, Stone EJ, Yang M, Lytle L, Webber L. The effects of the Child and Adolescent Trial for Cardiovascular Health upon psychosocial determinants of diet and physical activity behavior. Prev Med. 1996 Jul-Aug;25(4):442-54. doi: 10.1006/pmed.1996.0076.

  PMID: 8812822 BACKGROUND

• Edmundson E, Parcel GS, Perry CL, Feldman HA, Smyth M, Johnson CC, Layman A, Bachman K, Perkins T, Smith K, Stone E. The effects of the child and adolescent trial for cardiovascular health intervention on psychosocial determinants of cardiovascular disease risk behavior among third-grade students. Am J Health Promot. 1996 Jan-Feb;10(3):217-25. doi: 10.4278/0890-1171-10.3.217.

  PMID: 10163302 BACKGROUND

• Birch LL, Fisher JO, Grimm-Thomas K, Markey CN, Sawyer R, Johnson SL. Confirmatory factor analysis of the Child Feeding Questionnaire: a measure of parental attitudes, beliefs and practices about child feeding and obesity proneness. Appetite. 2001 Jun;36(3):201-10. doi: 10.1006/appe.2001.0398.

  PMID: 11358344 BACKGROUND

• Davison KK, Li K, Baskin ML, Cox T, Affuso O. Measuring parental support for children's physical activity in white and African American parents: the Activity Support Scale for Multiple Groups (ACTS-MG). Prev Med. 2011 Jan;52(1):39-43. doi: 10.1016/j.ypmed.2010.11.008. Epub 2010 Nov 25.

  PMID: 21111755 BACKGROUND

• Dickin KL, Hill TF, Dollahite JS. Practice-based evidence of effectiveness in an integrated nutrition and parenting education intervention for low-income parents. J Acad Nutr Diet. 2014 Jun;114(6):945-950. doi: 10.1016/j.jand.2013.09.029. Epub 2013 Dec 4.

  PMID: 24315130 BACKGROUND

• Dickin KL, Lent M, Lu AH, Sequeira J, Dollahite JS. Developing a measure of behavior change in a program to help low-income parents prevent unhealthful weight gain in children. J Nutr Educ Behav. 2012 Jan-Feb;44(1):12-21. doi: 10.1016/j.jneb.2011.02.015. Epub 2011 Oct 13.

  PMID: 21996430 BACKGROUND

• Block G, Gillespie C, Rosenbaum EH, Jenson C. A rapid food screener to assess fat and fruit and vegetable intake. Am J Prev Med. 2000 May;18(4):284-8. doi: 10.1016/s0749-3797(00)00119-7.

  PMID: 10788730 BACKGROUND

• Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.

  PMID: 4053261 BACKGROUND

• Kelder S, Hoelscher DM, Barroso CS, Walker JL, Cribb P, Hu S. The CATCH Kids Club: a pilot after-school study for improving elementary students' nutrition and physical activity. Public Health Nutr. 2005 Apr;8(2):133-40. doi: 10.1079/phn2004678.

  PMID: 15877906 BACKGROUND

• Hoelscher DM, Day RS, Kelder SH, Ward JL. Reproducibility and validity of the secondary level School-Based Nutrition Monitoring student questionnaire. J Am Diet Assoc. 2003 Feb;103(2):186-94. doi: 10.1053/jada.2003.50031.

  PMID: 12589324 BACKGROUND

• Inokuchi M, Matsuo N, Takayama JI, Hasegawa T. BMI z-score is the optimal measure of annual adiposity change in elementary school children. Ann Hum Biol. 2011 Nov;38(6):747-51. doi: 10.3109/03014460.2011.620625.

  PMID: 22014004 BACKGROUND

• Massey OT. A proposed model for the analysis and interpretation of focus groups in evaluation research. Eval Program Plann. 2011 Feb;34(1):21-8. doi: 10.1016/j.evalprogplan.2010.06.003. Epub 2010 Jul 3.

  PMID: 20655593 BACKGROUND

• Creswell JW. Qualitative inquiry & research design: Choosing among five approaches (2nd ed). SAGE: Thousand Oaks, CA. 2007

  BACKGROUND

• Strauss A. Qualitative analysis for social scientists. Cambridge University Press: Cambridge, England. 1987

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• 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

  BACKGROUND

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Population Health Sciences & Director, Center for Public Health Practice and Research

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 10, 2019
• Study Start: February 19, 2019
• Primary Completion: September 11, 2021
• Study Completion: September 11, 2021
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)