Trial Outcomes & Findings for Healthy Home Offerings Via the Mealtime Environment (HOME) Plus (NCT NCT01538615)

Last Updated: 2018-03-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

413 participants

Primary outcome timeframe

Change from Baseline at 12 and 21 months

Results posted on

2018-03-01

Participant Flow

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).

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	162	158
Overall Study COMPLETED	140	146
Overall Study NOT COMPLETED	22	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This row reports on the the child BMIz scores. Parent BMI will be reported in the following row.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HOME Plus Intervention n=162 Participants 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.	Control n=158 Participants 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.	Total n=320 Participants Total of all reporting groups
Age, Customized mean child age	10.5 years STANDARD_DEVIATION 1.4 • n=162 Participants	10.1 years STANDARD_DEVIATION 1.4 • n=158 Participants	10.4 years STANDARD_DEVIATION 1.4 • n=320 Participants
Age, Customized mean parent age	41.3 years STANDARD_DEVIATION 8.0 • n=162 Participants	41.3 years STANDARD_DEVIATION 7.4 • n=158 Participants	41.3 years STANDARD_DEVIATION 7.7 • n=320 Participants
Sex/Gender, Customized gender · Male	48 Participants n=162 Participants	45 Participants n=158 Participants	93 Participants n=320 Participants
Sex/Gender, Customized gender · Female	114 Participants n=162 Participants	113 Participants n=158 Participants	227 Participants n=320 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=162 Participants	11 Participants n=158 Participants	20 Participants n=320 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	153 Participants n=162 Participants	147 Participants n=158 Participants	300 Participants n=320 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=162 Participants	0 Participants n=158 Participants	0 Participants n=320 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=162 Participants	6 Participants n=158 Participants	8 Participants n=320 Participants
Race (NIH/OMB) Asian	3 Participants n=162 Participants	1 Participants n=158 Participants	4 Participants n=320 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=162 Participants	0 Participants n=158 Participants	0 Participants n=320 Participants
Race (NIH/OMB) Black or African American	25 Participants n=162 Participants	27 Participants n=158 Participants	52 Participants n=320 Participants
Race (NIH/OMB) White	119 Participants n=162 Participants	113 Participants n=158 Participants	232 Participants n=320 Participants
Race (NIH/OMB) More than one race	13 Participants n=162 Participants	11 Participants n=158 Participants	24 Participants n=320 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=162 Participants	0 Participants n=158 Participants	0 Participants n=320 Participants
Region of Enrollment United States	162 participants n=162 Participants	158 participants n=158 Participants	320 participants n=320 Participants
child BMIz	0.95 Z-score STANDARD_DEVIATION 0.78 • n=81 Participants • This row reports on the the child BMIz scores. Parent BMI will be reported in the following row.	1.02 Z-score STANDARD_DEVIATION 0.73 • n=79 Participants • This row reports on the the child BMIz scores. Parent BMI will be reported in the following row.	0.99 Z-score STANDARD_DEVIATION 0.75 • n=160 Participants • This row reports on the the child BMIz scores. Parent BMI will be reported in the following row.
parent BMI	27.64 kg/m^2 STANDARD_DEVIATION 7.14 • n=81 Participants • This row reports on the values for parent BMI. Child BMIz were reported in the previous row.	29.64 kg/m^2 STANDARD_DEVIATION 7.68 • n=79 Participants • This row reports on the values for parent BMI. Child BMIz were reported in the previous row.	28.63 kg/m^2 STANDARD_DEVIATION 7.46 • n=160 Participants • This row reports on the values for parent BMI. Child BMIz were reported in the previous row.
receiving economic assistance	72 Participants n=162 Participants	52 Participants n=158 Participants	124 Participants n=320 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HOME Plus Intervention n=74 Participants 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.	Control n=75 Participants 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.
Change in Child Body Mass Index (BMI Z-score) Post Intervention (12 months after baseline)	0.95 z-score Standard Error 0.04	0.99 z-score Standard Error 0.04
Change in Child Body Mass Index (BMI Z-score) Follow-up (21 months after baseline)	0.94 z-score Standard Error 0.04	1.01 z-score Standard Error 0.04

SECONDARY outcome

Timeframe: Change from Baseline at 12 and 21 months

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.

Outcome measures

Outcome measures
Measure	HOME Plus Intervention n=74 Participants 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.	Control n=75 Participants 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.
Change in Target Children's Daily Intakes of Fruits and Vegetables Post Intervention (12 months after baseline)	2.7 average servings Standard Error 0.19	2.5 average servings Standard Error 0.18
Change in Target Children's Daily Intakes of Fruits and Vegetables Follow-up (21 months after baseline)	2.5 average servings Standard Error 0.19	2.6 average servings Standard Error 0.18

SECONDARY outcome

Timeframe: Change from Baseline at 12 and 21 months

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.

Outcome measures

Outcome measures
Measure	HOME Plus Intervention n=74 Participants 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.	Control n=75 Participants 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.
Change in Target Children's Hours of Screen Time (Television Viewing, Video and Computer Game Playing) Per Week Post Intervention (12 months after baseline)	33.0 hours per week Standard Error 3.06	33.0 hours per week Standard Error 3.00
Change in Target Children's Hours of Screen Time (Television Viewing, Video and Computer Game Playing) Per Week Follow-up (21 months after baseline)	34.4 hours per week Standard Error 3.13	41.7 hours per week Standard Error 3.03

SECONDARY outcome

Timeframe: Change from Baseline at 12 and 21 months

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.

Outcome measures

Outcome measures
Measure	HOME Plus Intervention n=74 Participants 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.	Control n=75 Participants 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.
Change in Number of Fruits and Vegetables Available in the Home Follow-up (21 months after baseline)	21.6 number of fruits and vegetables Standard Error 0.89	21.9 number of fruits and vegetables Standard Error 0.86
Change in Number of Fruits and Vegetables Available in the Home Post Intervention (12 months after baseline)	22.5 number of fruits and vegetables Standard Error 0.88	20.4 number of fruits and vegetables Standard Error 0.86

Adverse Events

HOME Plus Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jayne A. Fulkerson

University of Minnesota School of Nursing

Phone: 612-624-4823

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place