Trial Outcomes & Findings for Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers (NCT NCT04373434)
NCT ID: NCT04373434
Last Updated: 2025-10-22
Results Overview
Description: The USDA HEI measures diet quality and is calculated from two telephone administered 24-hr dietary recalls (one weekday, one weekend day). The HEI evaluates foods with a scoring system using 13 components for different food groups and the key recommendations of the 2015-2020 "Dietary Guidelines for Americans." Scores range from 0 to 100 where a score of 100 is an ideal score indicating that a diet follows the key recommendations of the 2015-2020 "Dietary Guidelines for Americans" (higher scores indicate better diet quality).
COMPLETED
NA
512 participants
Baseline, Month 4, Month 9
2025-10-22
Participant Flow
Participants were recruited from the United Way of Greater Atlanta 2-1-1, United Way of Central Georgia, United Way of the Chattahoochee Valley 2-1-1, and United Way of Southwest Georgia as part of a hybrid effectiveness implementation trial testing an adapted version of the Healthy Homes/Healthy Families healthy eating and weight gain prevention intervention. Participant enrollment began in September 2020, and final follow-up assessments were completed in December 2022.
Participant milestones
| Measure |
Healthy Homes/Healthy Families (HH/HF) Intervention
Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.
|
Control
Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate
|
|---|---|---|
|
Overall Study
STARTED
|
255
|
257
|
|
Overall Study
COMPLETED
|
208
|
220
|
|
Overall Study
NOT COMPLETED
|
47
|
37
|
Reasons for withdrawal
| Measure |
Healthy Homes/Healthy Families (HH/HF) Intervention
Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.
|
Control
Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
37
|
32
|
|
Overall Study
Refused at 9 months
|
1
|
2
|
|
Overall Study
Refused at 4 months
|
7
|
3
|
|
Overall Study
Excluded
|
2
|
0
|
Baseline Characteristics
Some participants did not provide information for every baseline characteristic
Baseline characteristics by cohort
| Measure |
Healthy Homes/Healthy Families (HH/HF) Intervention
n=253 Participants
Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.
|
Control
n=257 Participants
Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate
|
Total
n=510 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 12.2 • n=253 Participants
|
43.0 years
STANDARD_DEVIATION 11.7 • n=257 Participants
|
43.4 years
STANDARD_DEVIATION 11.4 • n=510 Participants
|
|
Sex: Female, Male
Female
|
230 Participants
n=253 Participants
|
237 Participants
n=257 Participants
|
467 Participants
n=510 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=253 Participants
|
20 Participants
n=257 Participants
|
43 Participants
n=510 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=253 Participants
|
7 Participants
n=257 Participants
|
10 Participants
n=510 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=253 Participants
|
0 Participants
n=257 Participants
|
0 Participants
n=510 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
250 Participants
n=253 Participants
|
250 Participants
n=257 Participants
|
500 Participants
n=510 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian, Alaska Native Asian
|
3 Participants
n=251 Participants • Some participants did not provide information for every baseline characteristic
|
0 Participants
n=252 Participants • Some participants did not provide information for every baseline characteristic
|
3 Participants
n=503 Participants • Some participants did not provide information for every baseline characteristic
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
0 Participants
n=251 Participants • Some participants did not provide information for every baseline characteristic
|
0 Participants
n=252 Participants • Some participants did not provide information for every baseline characteristic
|
0 Participants
n=503 Participants • Some participants did not provide information for every baseline characteristic
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
206 Participants
n=251 Participants • Some participants did not provide information for every baseline characteristic
|
210 Participants
n=252 Participants • Some participants did not provide information for every baseline characteristic
|
416 Participants
n=503 Participants • Some participants did not provide information for every baseline characteristic
|
|
Race/Ethnicity, Customized
Race · White
|
31 Participants
n=251 Participants • Some participants did not provide information for every baseline characteristic
|
21 Participants
n=252 Participants • Some participants did not provide information for every baseline characteristic
|
52 Participants
n=503 Participants • Some participants did not provide information for every baseline characteristic
|
|
Race/Ethnicity, Customized
Race · More than one race
|
8 Participants
n=251 Participants • Some participants did not provide information for every baseline characteristic
|
14 Participants
n=252 Participants • Some participants did not provide information for every baseline characteristic
|
22 Participants
n=503 Participants • Some participants did not provide information for every baseline characteristic
|
|
Race/Ethnicity, Customized
Race · Unknown or not reported
|
3 Participants
n=251 Participants • Some participants did not provide information for every baseline characteristic
|
7 Participants
n=252 Participants • Some participants did not provide information for every baseline characteristic
|
10 Participants
n=503 Participants • Some participants did not provide information for every baseline characteristic
|
|
Highest education
Less than high school
|
20 Participants
n=253 Participants
|
24 Participants
n=257 Participants
|
44 Participants
n=510 Participants
|
|
Highest education
High school or GED
|
66 Participants
n=253 Participants
|
86 Participants
n=257 Participants
|
152 Participants
n=510 Participants
|
|
Highest education
Some college/technical school
|
103 Participants
n=253 Participants
|
91 Participants
n=257 Participants
|
194 Participants
n=510 Participants
|
|
Highest education
College graduate or higher
|
64 Participants
n=253 Participants
|
56 Participants
n=257 Participants
|
120 Participants
n=510 Participants
|
|
Employment status
Employed
|
143 Participants
n=253 Participants
|
138 Participants
n=257 Participants
|
281 Participants
n=510 Participants
|
|
Employment status
Not Employed
|
110 Participants
n=253 Participants
|
119 Participants
n=257 Participants
|
229 Participants
n=510 Participants
|
|
Household income
$10,000 and under
|
66 Participants
n=241 Participants • Some participants did not provide information for every baseline characteristic.
|
70 Participants
n=246 Participants • Some participants did not provide information for every baseline characteristic.
|
136 Participants
n=487 Participants • Some participants did not provide information for every baseline characteristic.
|
|
Household income
$10,001 - $20,000
|
57 Participants
n=241 Participants • Some participants did not provide information for every baseline characteristic.
|
67 Participants
n=246 Participants • Some participants did not provide information for every baseline characteristic.
|
124 Participants
n=487 Participants • Some participants did not provide information for every baseline characteristic.
|
|
Household income
$20,001 - $35,000
|
55 Participants
n=241 Participants • Some participants did not provide information for every baseline characteristic.
|
67 Participants
n=246 Participants • Some participants did not provide information for every baseline characteristic.
|
122 Participants
n=487 Participants • Some participants did not provide information for every baseline characteristic.
|
|
Household income
$35,001 - $50,000
|
35 Participants
n=241 Participants • Some participants did not provide information for every baseline characteristic.
|
27 Participants
n=246 Participants • Some participants did not provide information for every baseline characteristic.
|
62 Participants
n=487 Participants • Some participants did not provide information for every baseline characteristic.
|
|
Household income
More than $50,000
|
28 Participants
n=241 Participants • Some participants did not provide information for every baseline characteristic.
|
15 Participants
n=246 Participants • Some participants did not provide information for every baseline characteristic.
|
43 Participants
n=487 Participants • Some participants did not provide information for every baseline characteristic.
|
|
Marital status
Married/living with partner
|
63 Participants
n=253 Participants
|
49 Participants
n=257 Participants
|
112 Participants
n=510 Participants
|
|
Marital status
Widowed/separated/divorced
|
62 Participants
n=253 Participants
|
56 Participants
n=257 Participants
|
118 Participants
n=510 Participants
|
|
Marital status
Not married
|
128 Participants
n=253 Participants
|
152 Participants
n=257 Participants
|
280 Participants
n=510 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 4, Month 9Population: Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above
Description: The USDA HEI measures diet quality and is calculated from two telephone administered 24-hr dietary recalls (one weekday, one weekend day). The HEI evaluates foods with a scoring system using 13 components for different food groups and the key recommendations of the 2015-2020 "Dietary Guidelines for Americans." Scores range from 0 to 100 where a score of 100 is an ideal score indicating that a diet follows the key recommendations of the 2015-2020 "Dietary Guidelines for Americans" (higher scores indicate better diet quality).
Outcome measures
| Measure |
Healthy Homes/Healthy Families (HH/HF) Intervention
n=253 Participants
Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.
|
Control
n=257 Participants
Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate
|
|---|---|---|
|
Change in United States Department of Agriculture (USDA) Healthy Eating Index (HEI)
Baseline
|
51.0 units on a scale
Standard Deviation 12.3
|
52.6 units on a scale
Standard Deviation 12.9
|
|
Change in United States Department of Agriculture (USDA) Healthy Eating Index (HEI)
Month 4 (Mean change from baseline )
|
3.38 units on a scale
Standard Deviation 14.45
|
0.92 units on a scale
Standard Deviation 14.06
|
|
Change in United States Department of Agriculture (USDA) Healthy Eating Index (HEI)
Month 9 (Mean change from baseline )
|
2.74 units on a scale
Standard Deviation 14.57
|
-0.27 units on a scale
Standard Deviation 14.10
|
SECONDARY outcome
Timeframe: Baseline, Month 4, Month 9Population: Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above.
Kcal per day will be calculated and recorded. The most recent version of the Automated Self-Administered 24-hour dietary recall (ASA24) program prompts for food description details and automatically codes and calculates nutrient intakes using the USDA Food and Nutrient Database for Dietary Studies. The average of one weekday and one weekend day will be used to estimate Kcal per day at each time point.
Outcome measures
| Measure |
Healthy Homes/Healthy Families (HH/HF) Intervention
n=253 Participants
Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.
|
Control
n=257 Participants
Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate
|
|---|---|---|
|
Change in Kcal Per Day Intake
Baseline
|
1736 Kcal/day
Standard Deviation 863.0
|
1718 Kcal/day
Standard Deviation 784.5
|
|
Change in Kcal Per Day Intake
Month 4 (Mean change)
|
-206 Kcal/day
Standard Deviation 757
|
-80 Kcal/day
Standard Deviation 743
|
|
Change in Kcal Per Day Intake
Month 9 (Mean change)
|
-155 Kcal/day
Standard Deviation 908
|
-93 Kcal/day
Standard Deviation 763
|
SECONDARY outcome
Timeframe: Baseline, Month 4, Month 9Population: Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above
Participants will self-report weight in pounds each time point
Outcome measures
| Measure |
Healthy Homes/Healthy Families (HH/HF) Intervention
n=253 Participants
Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.
|
Control
n=257 Participants
Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate
|
|---|---|---|
|
Change in Self-reported Weight
Baseline
|
202.3 weight in pounds (lbs)
Standard Deviation 53.1
|
204.1 weight in pounds (lbs)
Standard Deviation 51.9
|
|
Change in Self-reported Weight
Month 4 (Mean change from baseline )
|
-6.5 weight in pounds (lbs)
Standard Deviation 21.74
|
-2.9 weight in pounds (lbs)
Standard Deviation 19.31
|
|
Change in Self-reported Weight
Month 9 (Mean change from baseline)
|
-4.5 weight in pounds (lbs)
Standard Deviation 20.64
|
-2.5 weight in pounds (lbs)
Standard Deviation 21.17
|
SECONDARY outcome
Timeframe: Baseline, Month 4, Month 9Population: Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above
Participants were asked about unhealthy snacks and foods, ranging from 0 to 8, in each survey of the household food inventory. The higher the number the more unhealthy snacks/foods were reported
Outcome measures
| Measure |
Healthy Homes/Healthy Families (HH/HF) Intervention
n=253 Participants
Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.
|
Control
n=257 Participants
Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate
|
|---|---|---|
|
Changes to Food Environment: UNHEALTHY SNACKS/FOODS INVENTORY, OF 8
Baseline
|
4.29 number of unhealthy snacks in the home
Standard Deviation 1.71
|
4.45 number of unhealthy snacks in the home
Standard Deviation 1.72
|
|
Changes to Food Environment: UNHEALTHY SNACKS/FOODS INVENTORY, OF 8
Month 4
|
-1.12 number of unhealthy snacks in the home
Standard Deviation 2.05
|
-0.18 number of unhealthy snacks in the home
Standard Deviation 1.90
|
|
Changes to Food Environment: UNHEALTHY SNACKS/FOODS INVENTORY, OF 8
Month 9
|
-0.75 number of unhealthy snacks in the home
Standard Deviation 2.18
|
-0.39 number of unhealthy snacks in the home
Standard Deviation 2.10
|
SECONDARY outcome
Timeframe: Baseline, Month 4, Month 9Population: Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above
A home environment survey assessed the frequency of shopping for or bringing home fruits and vegetables in the past month. Response options were 1=less than once per week, 2=once per week, or 3=more than once per week. Anyone who purchased fruits or vegetables at least once a week was scored as 1, while all others were scored as zero. Reporting includes the percentage of participants who scored 1, i.e., purchased fruits or vegetables at least once a week.
Outcome measures
| Measure |
Healthy Homes/Healthy Families (HH/HF) Intervention
n=252 Participants
Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.
|
Control
n=257 Participants
Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate
|
|---|---|---|
|
Changes to Food Environment: PURCHASING FRUITS/VEGETABLES ≥1/WK
Month 4
|
10.8 percentage of participants
|
4.7 percentage of participants
|
|
Changes to Food Environment: PURCHASING FRUITS/VEGETABLES ≥1/WK
Month 9
|
7.2 percentage of participants
|
5.5 percentage of participants
|
|
Changes to Food Environment: PURCHASING FRUITS/VEGETABLES ≥1/WK
Baseline
|
76.19 percentage of participants
|
72.37 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 4, Month 9Population: Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above
Participants were asked about 16 food preparation methods and 3 food serving practices focused on portion control (e.g., use of smaller plates) in the past month. Response options were 1=never/rarely, 2=occasionally, 3=often, and 4=very often. Unhealthy food prep items were reverse-coded, and then all items were averaged. The higher the number, the more frequently healthy food preparation methods were used, and unhealthy food preparation methods were used less frequently
Outcome measures
| Measure |
Healthy Homes/Healthy Families (HH/HF) Intervention
n=253 Participants
Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.
|
Control
n=257 Participants
Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate
|
|---|---|---|
|
Changes to Food Environment: HEALTHY FOOD PREPARATION
Baseline
|
2.10 units on a scale
Standard Deviation 0.44
|
2.12 units on a scale
Standard Deviation 0.45
|
|
Changes to Food Environment: HEALTHY FOOD PREPARATION
Month 4 (mean change from baseline)
|
0.21 units on a scale
Standard Deviation 0.49
|
-0.02 units on a scale
Standard Deviation 0.40
|
|
Changes to Food Environment: HEALTHY FOOD PREPARATION
Month 9 (mean change from baseline)
|
0.20 units on a scale
Standard Deviation 0.48
|
0.05 units on a scale
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: Baseline, Month 4, Month 9Population: Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above
A home environment survey assessed non-home food sources. Participants were asked how many days in the last week (never, 1-7) they purchased a family meal from four non-home food sources (e.g. fast food, convenience store). The total score was calculated by adding the four types of meals with possible scores ranging from 0 to 28. A higher score indicated more family meals per week from non-home sources.
Outcome measures
| Measure |
Healthy Homes/Healthy Families (HH/HF) Intervention
n=253 Participants
Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.
|
Control
n=257 Participants
Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate
|
|---|---|---|
|
Changes to Food Environment: FAMILY MEALS FROM NONHOME SOURCES, DAYS IN PAST WEEK
Baseline
|
3.27 meals per week
Standard Deviation 3.50
|
2.88 meals per week
Standard Deviation 2.94
|
|
Changes to Food Environment: FAMILY MEALS FROM NONHOME SOURCES, DAYS IN PAST WEEK
Month 4 (mean change from baseline)
|
-0.59 meals per week
Standard Deviation 3.59
|
-0.12 meals per week
Standard Deviation 3.02
|
|
Changes to Food Environment: FAMILY MEALS FROM NONHOME SOURCES, DAYS IN PAST WEEK
Month 9 (mean change from baseline)
|
-0.67 meals per week
Standard Deviation 4.30
|
-0.01 meals per week
Standard Deviation 3.44
|
SECONDARY outcome
Timeframe: Baseline, Month 4, Month 9Population: Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above
A home environment survey included two items on meals/snacks eaten with the television on. Response options ranged: 1=never/rarely, 2=occasionally, 3=often, 4=very often. The score was calculated as the mean of both items. A higher score indicates more frequently eaten meals and snacks with the television on.
Outcome measures
| Measure |
Healthy Homes/Healthy Families (HH/HF) Intervention
n=253 Participants
Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.
|
Control
n=257 Participants
Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate
|
|---|---|---|
|
Changes to Food Environment: Family Eating and TV
Baseline
|
2.65 units on a scale
Standard Deviation 1.02
|
2.58 units on a scale
Standard Deviation 1.09
|
|
Changes to Food Environment: Family Eating and TV
Month 4 (mean change from baseline)
|
-0.55 units on a scale
Standard Deviation 1.08
|
-0.16 units on a scale
Standard Deviation 1.03
|
|
Changes to Food Environment: Family Eating and TV
Month 9 (mean change from baseline)
|
-0.45 units on a scale
Standard Deviation 1.10
|
-0.17 units on a scale
Standard Deviation 1.04
|
Adverse Events
Healthy Homes/Healthy Families (HH/HF) Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place