Healthy Home Offerings Via the Mealtime Environment (HOME) Plus

NCT ID: NCT01538615

Last Updated: 2018-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 413 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2016-06-30

Brief Summary

The goal of the proposed project is to see if an innovative family-based intervention can reduce childhood obesity by actively engaging the whole family in promoting healthy behaviors in the home. In additions, the project will also examine how the HOME Plus family intervention influences children's dietary intake, frequency of family meals, availability of healthy and unhealthy foods in the home and served at meals and snacks, and screen time (TV, game systems). The study will provide important information on strategies that families can use at home to prevent obesity.

Detailed Description

Childhood obesity is a serious public health problem with limited effective prevention strategies to date. Although previous nutrition and physical activity environmental approaches for obesity prevention show some promise, most studies have not shown reductions in excess weight gain. Moreover, few prevention studies significantly engage parents and focus on the home environment. To prevent childhood obesity it is essential to promote healthy behaviors in the home environment because parents are influential primary role models for healthy eating and sedentary behavior, and are gatekeepers for food and beverage availability and degree of inactivity within the home. Moreover, the home setting is where most of children's calories and energy dense foods are consumed and where children engage in much of their sedentary behavior, particularly screen time (e.g., television, computer, game system). The proposed study will test the efficacy of the Healthy Home Offerings via the Mealtime Environment (HOME) Plus program, a ten-month, family-based health promotion intervention to prevent excess weight gain among 8-12 year old children. The program is based on Social Cognitive Theory and a socio-ecological framework and promotes both regular and nutritionally-sound snacks and meals in which family members eat together (i.e., family meals) and encourages reductions in sedentary behavior, particularly screen time among children in the home setting. The efficacy of the intervention will be tested in a randomized controlled trial with 160 families randomized to two conditions (intervention or attention-only control). Two cohorts of families, recruited from after-school programs and community centers, will be followed for 2.5 years. The primary hypothesis is that, by the end of the ten month intervention, target children in the intervention families, relative to children in the control families, will have significantly lower body mass index (BMI; primary outcome) after adjustment for baseline BMI values. Secondary outcomes include frequency of weekly family meals and number of healthful foods and beverages available in the home and served at family meals and snacks (as reported by parent), target children's daily intakes of healthful foods and beverages, and target children's minutes of sedentary behavior per week, particularly screen time. Child and parent measurement will occur in their homes at baseline, post-intervention (12-months post-randomization), and follow-up (9-months post-intervention) by trained research staff. The proposed study builds upon successful methods from our HOME pilot study (2006-2008; NIH R21-DK0072997) and is innovative as it actively engages entire families in experiential activities and capitalizes on the home setting. The study will provide important information on environmental and behavioral strategies that families can use at home to prevent excess weight gain. The intervention program has high translation potential and is likely to be immediately useful to families of school-age children because it will be tested in real-world community settings and sustained across the state of Minnesota by the University of Minnesota's Extension Service.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HOME Plus Intervention

described below

Group Type: EXPERIMENTAL

HOME Plus intervention

Intervention Type: BEHAVIORAL

The HOME Plus program families will participate in monthly, two-hour group sessions for ten months at local community centers. Each session offers new ideas focusing on family meals, healthy eating, and reducing sedentary behavior. At each session, families prepare and eat a meal together and participate in small group discussions and activities for both parent and child groups to promote healthy behaviors in the home. Topics include planning healthy meals and snacks with your family, having meals with your family more often, and improving the healthfulness of the food available at home. Families also receive periodic supportive phone calls throughout the year using motivational interviewing techniques to promote healthy behaviors to prevent and reduce childhood obesity.

Control

Control participants receive a monthly newsletter for the 10 months of the study with tips on healthy eating. The topics do not overlap the intervention content.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HOME Plus intervention

The HOME Plus program families will participate in monthly, two-hour group sessions for ten months at local community centers. Each session offers new ideas focusing on family meals, healthy eating, and reducing sedentary behavior. At each session, families prepare and eat a meal together and participate in small group discussions and activities for both parent and child groups to promote healthy behaviors in the home. Topics include planning healthy meals and snacks with your family, having meals with your family more often, and improving the healthfulness of the food available at home. Families also receive periodic supportive phone calls throughout the year using motivational interviewing techniques to promote healthy behaviors to prevent and reduce childhood obesity.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• the target child is between the ages of 8-12 years
• the target adult parent or guardian is the primary food preparer in the home
• target child has an age and gender adjusted body mass index at or above the 50th percentile
• participants are willing to be randomized into one of two groups (intervention or control)
• target child must live with participating adult most of the time

Exclusion Criteria

• participants plan to move out of the area in the next six months
• participants have a severe food allergy, limitation, or medical condition that prevents them from participating in the intervention
• participants do not speak and read in English

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jayne A Fulkerson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota, School of Nursing

Locations

University of Minnesota, School of Nursing

Minneapolis, Minnesota, United States

Countries

United States

References

Fulkerson JA, Neumark-Sztainer D, Story M, Gurvich O, Kubik MY, Garwick A, Dudovitz B. The Healthy Home Offerings via the Mealtime Environment (HOME) Plus study: design and methods. Contemp Clin Trials. 2014 May;38(1):59-68. doi: 10.1016/j.cct.2014.01.006. Epub 2014 Jan 27.

Reference Type: BACKGROUND

PMID: 24480729 (View on PubMed)

Draxten M, Fulkerson JA, Friend S, Flattum CF, Schow R. Parental role modeling of fruits and vegetables at meals and snacks is associated with children's adequate consumption. Appetite. 2014 Jul;78:1-7. doi: 10.1016/j.appet.2014.02.017. Epub 2014 Mar 12.

Reference Type: RESULT

PMID: 24630934 (View on PubMed)

Friend S, Fulkerson JA, Neumark-Sztainer D, Garwick A, Flattum CF, Draxten M. Comparing childhood meal frequency to current meal frequency, routines, and expectations among parents. J Fam Psychol. 2015 Feb;29(1):136-40. doi: 10.1037/fam0000046. Epub 2014 Dec 8.

Reference Type: RESULT

PMID: 25485670 (View on PubMed)

Flattum C, Draxten M, Horning M, Fulkerson JA, Neumark-Sztainer D, Garwick A, Kubik MY, Story M. HOME Plus: Program design and implementation of a family-focused, community-based intervention to promote the frequency and healthfulness of family meals, reduce children's sedentary behavior, and prevent obesity. Int J Behav Nutr Phys Act. 2015 Apr 29;12:53. doi: 10.1186/s12966-015-0211-7.

Reference Type: RESULT

PMID: 25925226 (View on PubMed)

Fulkerson JA, Friend S, Flattum C, Horning M, Draxten M, Neumark-Sztainer D, Gurvich O, Story M, Garwick A, Kubik MY. Promoting healthful family meals to prevent obesity: HOME Plus, a randomized controlled trial. Int J Behav Nutr Phys Act. 2015 Dec 15;12:154. doi: 10.1186/s12966-015-0320-3.

Reference Type: RESULT

PMID: 26667110 (View on PubMed)

Horning ML, Fulkerson JA, Friend SE, Neumark-Sztainer D. Associations among Nine Family Dinner Frequency Measures and Child Weight, Dietary, and Psychosocial Outcomes. J Acad Nutr Diet. 2016 Jun;116(6):991-9. doi: 10.1016/j.jand.2015.12.018. Epub 2016 Feb 10.

Reference Type: RESULT

PMID: 26875023 (View on PubMed)

Draxten M, Flattum C, Fulkerson J. An Example of How to Supplement Goal Setting to Promote Behavior Change for Families Using Motivational Interviewing. Health Commun. 2016 Oct;31(10):1276-83. doi: 10.1080/10410236.2015.1062975. Epub 2016 Mar 3.

Reference Type: RESULT

PMID: 26940585 (View on PubMed)

Loth KA, Friend S, Horning ML, Neumark-Sztainer D, Fulkerson JA. Directive and non-directive food-related parenting practices: Associations between an expanded conceptualization of food-related parenting practices and child dietary intake and weight outcomes. Appetite. 2016 Dec 1;107:188-195. doi: 10.1016/j.appet.2016.07.036. Epub 2016 Jul 31.

Reference Type: RESULT

PMID: 27486926 (View on PubMed)

Horning ML, Fulkerson JA, Friend SE, Story M. Reasons Parents Buy Prepackaged, Processed Meals: It Is More Complicated Than "I Don't Have Time". J Nutr Educ Behav. 2017 Jan;49(1):60-66.e1. doi: 10.1016/j.jneb.2016.08.012. Epub 2016 Oct 12.

Reference Type: RESULT

PMID: 27743860 (View on PubMed)

Kubik MY, Gurvich OV, Fulkerson JA. Association Between Parent Television-Viewing Practices and Setting Rules to Limit the Television-Viewing Time of Their 8- to 12-Year-Old Children, Minnesota, 2011-2015. Prev Chronic Dis. 2017 Jan 19;14:E06. doi: 10.5888/pcd14.160235.

Reference Type: RESULT

PMID: 28103183 (View on PubMed)

Lee J, Helgeson E, Horning ML, Elgesma KM, Kubik MY, Fulkerson JA. Food Insecurity and Changes in Diet Quality and Body Mass Index z-Scores Among Elementary School Students. Child Obes. 2024 Oct;20(7):508-516. doi: 10.1089/chi.2023.0185. Epub 2024 Mar 28.

Reference Type: DERIVED

PMID: 38546529 (View on PubMed)

Lee J, Kubik MY, Fulkerson JA, Kohli N, Garwick AE. The Identification of Family Social Environment Typologies Using Latent Class Analysis: Implications for Future Family-Focused Research. J Fam Nurs. 2020 Feb;26(1):26-37. doi: 10.1177/1074840719894016. Epub 2019 Dec 25.

Reference Type: DERIVED

PMID: 31874588 (View on PubMed)

Lee J, Kubik MY, Fulkerson JA. Diet Quality and Fruit, Vegetable, and Sugar-Sweetened Beverage Consumption by Household Food Insecurity among 8- to 12-Year-Old Children during Summer Months. J Acad Nutr Diet. 2019 Oct;119(10):1695-1702. doi: 10.1016/j.jand.2019.03.004. Epub 2019 May 2.

Reference Type: DERIVED

PMID: 31056369 (View on PubMed)

Arcan C, Friend S, Flattum CF, Story M, Fulkerson JA. Fill "half your child's plate with fruits and vegetables": Correlations with food-related practices and the home food environment. Appetite. 2019 Feb 1;133:77-82. doi: 10.1016/j.appet.2018.10.017. Epub 2018 Oct 17.

Reference Type: DERIVED

PMID: 30339784 (View on PubMed)

Myers ML, Fulkerson JA, Friend SE, Horning ML, Flattum CF. Case study: Behavior changes in the family-focused obesity prevention HOME Plus program. Public Health Nurs. 2018 Jul;35(4):299-306. doi: 10.1111/phn.12403. Epub 2018 Apr 6.

Reference Type: DERIVED

PMID: 29624720 (View on PubMed)

Other Identifiers

R01DK084000-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20521

Identifier Type: -

Identifier Source: org_study_id