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Healthy Home Offerings Via the Mealtime Environment (HOME) Plus

Healthy Home Offerings Via the Mealtime Environment (HOME) Plus

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01538615
Enrollment
413
Registered
2012-02-24
Start date
2010-07-31
Completion date
2016-06-30
Last updated
2018-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Family meals, Home food environment, Electronic media

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.

Interventions

BEHAVIORALHOME 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.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

This is a behavioral intervention. Masking is not feasible.

Eligibility

Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Child Body Mass Index (BMI Z-score)Change from Baseline at 12 and 21 monthsTrained study staff will measure parent and child height and weight and use this to calculate body mass index (BMI). BMI values were than standardized for age and gender using CDC guidelines to obtain BMI z-scores. Analyses controlled for child age and parent education at baseline.

Secondary

MeasureTime frameDescription
Change in Target Children's Daily Intakes of Fruits and VegetablesChange from Baseline at 12 and 21 monthsA trained interviewer will complete three 24-hour dietary recalls at each data collection time point with the child. The three days will be averaged to get an estimate of usual intake. Analyses controlled for child age and parent education at baseline.
Change in Target Children's Hours of Screen Time (Television Viewing, Video and Computer Game Playing) Per WeekChange from Baseline at 12 and 21 monthsScreen time will be measured with survey questions asking children how many hours per day they spend doing each sedentary activity (such as watching TV, using the computer, playing video games). Separate questions will be asked for week days and weekend days then the will be weighted to determine the hours of sedentary activity per week. Analyses controlled for child age and parent education at baseline.
Change in Number of Fruits and Vegetables Available in the HomeChange from Baseline at 12 and 21 monthsThe HOME Food Inventory assesses which foods families currently have in their home from a list of items. Analyses controlled for child age and parent education.

Countries

United States

Participant flow

Pre-assignment details

Total study enrollment was 413. Of those, 93 were enrolled in focus groups designed to help develop an disseminate the study. The remaining 320 took part in the HOME Plus study as described 81 parent/child dyads were randomized into the intervention condition and 79 parent/child dyads were randomized into the control condition).

Participants by arm

ArmCount
HOME Plus Intervention
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.
162
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.
158
Total320

Baseline characteristics

CharacteristicControlHOME Plus InterventionTotal
Age, Customized
mean child age
10.1 years
STANDARD_DEVIATION 1.4
10.5 years
STANDARD_DEVIATION 1.4
10.4 years
STANDARD_DEVIATION 1.4
Age, Customized
mean parent age
41.3 years
STANDARD_DEVIATION 7.4
41.3 years
STANDARD_DEVIATION 8
41.3 years
STANDARD_DEVIATION 7.7
child BMIz1.02 Z-score
STANDARD_DEVIATION 0.73
0.95 Z-score
STANDARD_DEVIATION 0.78
0.99 Z-score
STANDARD_DEVIATION 0.75
Ethnicity (NIH/OMB)
Hispanic or Latino
11 Participants9 Participants20 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
147 Participants153 Participants300 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
parent BMI29.64 kg/m^2
STANDARD_DEVIATION 7.68
27.64 kg/m^2
STANDARD_DEVIATION 7.14
28.63 kg/m^2
STANDARD_DEVIATION 7.46
Race (NIH/OMB)
American Indian or Alaska Native
6 Participants2 Participants8 Participants
Race (NIH/OMB)
Asian
1 Participants3 Participants4 Participants
Race (NIH/OMB)
Black or African American
27 Participants25 Participants52 Participants
Race (NIH/OMB)
More than one race
11 Participants13 Participants24 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
113 Participants119 Participants232 Participants
receiving economic assistance52 Participants72 Participants124 Participants
Region of Enrollment
United States
158 participants162 participants320 participants
Sex/Gender, Customized
gender
Female
113 Participants114 Participants227 Participants
Sex/Gender, Customized
gender
Male
45 Participants48 Participants93 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1620 / 158
serious
Total, serious adverse events
0 / 1620 / 158

Outcome results

Primary

Change in Child Body Mass Index (BMI Z-score)

Trained study staff will measure parent and child height and weight and use this to calculate body mass index (BMI). BMI values were than standardized for age and gender using CDC guidelines to obtain BMI z-scores. Analyses controlled for child age and parent education at baseline.

Time frame: Change from Baseline at 12 and 21 months

Population: Numbers reported are for the child in the parent/child dyad. At post-intervention (12 months after baseline), 74 intervention children and 75 control children were measured. At follow-up (21 months after baseline) 70 intervention children and 73 control children were measured.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
HOME Plus InterventionChange in Child Body Mass Index (BMI Z-score)Post Intervention (12 months after baseline)0.95 z-scoreStandard Error 0.04
HOME Plus InterventionChange in Child Body Mass Index (BMI Z-score)Follow-up (21 months after baseline)0.94 z-scoreStandard Error 0.04
ControlChange in Child Body Mass Index (BMI Z-score)Post Intervention (12 months after baseline)0.99 z-scoreStandard Error 0.04
ControlChange in Child Body Mass Index (BMI Z-score)Follow-up (21 months after baseline)1.01 z-scoreStandard Error 0.04
Secondary

Change in Number of Fruits and Vegetables Available in the Home

The HOME Food Inventory assesses which foods families currently have in their home from a list of items. Analyses controlled for child age and parent education.

Time frame: Change from Baseline at 12 and 21 months

Population: Numbers reported are for the child in the parent/child dyad. At post-intervention (12 months after baseline), 74 intervention children and 75 control children were measured. At follow-up (21 months after baseline) 70 intervention children and 73 control children were measured.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
HOME Plus InterventionChange in Number of Fruits and Vegetables Available in the HomeFollow-up (21 months after baseline)21.6 number of fruits and vegetablesStandard Error 0.89
HOME Plus InterventionChange in Number of Fruits and Vegetables Available in the HomePost Intervention (12 months after baseline)22.5 number of fruits and vegetablesStandard Error 0.88
ControlChange in Number of Fruits and Vegetables Available in the HomePost Intervention (12 months after baseline)20.4 number of fruits and vegetablesStandard Error 0.86
ControlChange in Number of Fruits and Vegetables Available in the HomeFollow-up (21 months after baseline)21.9 number of fruits and vegetablesStandard Error 0.86
Secondary

Change in Target Children's Daily Intakes of Fruits and Vegetables

A trained interviewer will complete three 24-hour dietary recalls at each data collection time point with the child. The three days will be averaged to get an estimate of usual intake. Analyses controlled for child age and parent education at baseline.

Time frame: Change from Baseline at 12 and 21 months

Population: Numbers reported are for the child in the parent/child dyad. At post-intervention (12 months after baseline), 74 intervention children and 75 control children were measured. At follow-up (21 months after baseline) 70 intervention children and 73 control children were measured.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
HOME Plus InterventionChange in Target Children's Daily Intakes of Fruits and VegetablesPost Intervention (12 months after baseline)2.7 average servingsStandard Error 0.19
HOME Plus InterventionChange in Target Children's Daily Intakes of Fruits and VegetablesFollow-up (21 months after baseline)2.5 average servingsStandard Error 0.19
ControlChange in Target Children's Daily Intakes of Fruits and VegetablesPost Intervention (12 months after baseline)2.5 average servingsStandard Error 0.18
ControlChange in Target Children's Daily Intakes of Fruits and VegetablesFollow-up (21 months after baseline)2.6 average servingsStandard Error 0.18
Secondary

Change in Target Children's Hours of Screen Time (Television Viewing, Video and Computer Game Playing) Per Week

Screen time will be measured with survey questions asking children how many hours per day they spend doing each sedentary activity (such as watching TV, using the computer, playing video games). Separate questions will be asked for week days and weekend days then the will be weighted to determine the hours of sedentary activity per week. Analyses controlled for child age and parent education at baseline.

Time frame: Change from Baseline at 12 and 21 months

Population: Numbers reported are for the child in the parent/child dyad. At post-intervention (12 months after baseline), 74 intervention children and 75 control children were measured. At follow-up (21 months after baseline) 70 intervention children and 73 control children were measured.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
HOME Plus InterventionChange in Target Children's Hours of Screen Time (Television Viewing, Video and Computer Game Playing) Per WeekPost Intervention (12 months after baseline)33.0 hours per weekStandard Error 3.06
HOME Plus InterventionChange in Target Children's Hours of Screen Time (Television Viewing, Video and Computer Game Playing) Per WeekFollow-up (21 months after baseline)34.4 hours per weekStandard Error 3.13
ControlChange in Target Children's Hours of Screen Time (Television Viewing, Video and Computer Game Playing) Per WeekPost Intervention (12 months after baseline)33.0 hours per weekStandard Error 3
ControlChange in Target Children's Hours of Screen Time (Television Viewing, Video and Computer Game Playing) Per WeekFollow-up (21 months after baseline)41.7 hours per weekStandard Error 3.03

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026