An interventional study of Health Homes/Healthy Families (HH/HF) Intervention and Control in Weight Change, Body, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-10-22.
Sponsored by Emory University · Not applicable, Interventional, and Prevention
This trial will evaluate a healthy eating and weight gain prevention intervention for delivery through calls to the 2-1-1 number.
It is now well-established that obesity and excess weight increase the risk of cancer (i.e., colorectal and post-menopausal breast cancer), as well as other chronic diseases including diabetes, stroke, coronary heart disease, and arthritis. The World Cancer Research Fund and the American Institute for Cancer Research state "maintenance of a healthy weight throughout life may be one of the most important ways to protect against cancer". Unfortunately, adults generally gain weight as they age.
Healthy Homes/Healthy Families (HH/HF) Intervention involves a tailored home environment profile and a health coach working with participants to select and implement a series of healthy actions to create a home environment more supportive of healthy eating and physical activity.
The Federal Communications Commission (FCC) designated 2-1-1 as the 3-digit number to call for information and referrals to social services and other assistance in the United States. This study will evaluate a healthy eating and weight gain prevention intervention for delivery through 2-1-1 calls.
231 studies on the registry are indexed under Body Weight Changes; 30 are open to participants now.
This study's enrollment of 512 is above the median of 80 across 179 interventional studies indexed under Body Weight Changes.
Browse Body Weight Changes studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to the HH/HF study intervention will work with a coach through phone calls and text messages for 12 weeks to set goals targeting home-based environmental determinants of dietary behaviors.
Behavioral: Health Homes/Healthy Families (HH/HF) Intervention
Participants in the control condition will receive two mailings which focus on the same dietary outcomes as the HH/HF intervention but without the home environment emphasis.
Behavioral: Control
The HH/HF Intervention involves coaching calls, text messages and intervention materials that are designed to increase behavioral capability, self-efficacy and behavioral intention to improve the home food environment for healthy eating and weight gain prevention. The intervention is delivered over a 12 week period.
Participants in the control condition will receive two mailings on healthy eating, the first from the "Dietary Guidelines For Americans 2015-2020, 8th Edition" and the second from "Choose MyPlate". Additionally, both mailings will include a food diary from the Centers for Disease Control and Prevention. Mailings will be sent to participants one and six-weeks post-baseline. These materials focus on the same dietary outcomes being targeted in the HH/HF intervention, but without the home environment emphasis. Control group participants will receive their home environment profile with a list of healthy actions upon completion of the study.
Change in United States Department of Agriculture (USDA) Healthy Eating Index (HEI)
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).
Time frame: Baseline, Month 4, Month 9
Change in Kcal Per Day Intake
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.
Time frame: Baseline, Month 4, Month 9
Change in Self-reported Weight
Participants will self-report weight in pounds each time point
Time frame: Baseline, Month 4, Month 9
Changes to Food Environment: UNHEALTHY SNACKS/FOODS INVENTORY, OF 8
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
Time frame: Baseline, Month 4, Month 9
Changes to Food Environment: PURCHASING FRUITS/VEGETABLES ≥1/WK
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.
Time frame: Baseline, Month 4, Month 9
Changes to Food Environment: HEALTHY FOOD PREPARATION
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
Time frame: Baseline, Month 4, Month 9
Changes to Food Environment: FAMILY MEALS FROM NONHOME SOURCES, DAYS IN PAST WEEK
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.
Time frame: Baseline, Month 4, Month 9
Changes to Food Environment: Family Eating and TV
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.
Time frame: Baseline, Month 4, Month 9
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.
| Milestone | Healthy Homes/Healthy Families (HH/HF) Intervention | Control |
|---|---|---|
| Started | 255 | 257 |
| Completed | 208 | 220 |
| Not completed | 47 | 37 |
| Withdrew: Lost to follow-up | 37 | 32 |
| Withdrew: Refused at 9 months | 1 | 2 |
| Withdrew: Refused at 4 months | 7 | 3 |
| Withdrew: Excluded | 2 | 0 |
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).
| units on a scale | Healthy Homes/Healthy Families (HH/HF) Intervention | Control |
|---|---|---|
| Baseline | 51.0 ± 12.3 | 52.6 ± 12.9 |
| Month 4 (Mean change from baseline ) | 3.38 ± 14.45 | 0.92 ± 14.06 |
| Month 9 (Mean change from baseline ) | 2.74 ± 14.57 | -0.27 ± 14.10 |
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.
| Kcal/day | Healthy Homes/Healthy Families (HH/HF) Intervention | Control |
|---|---|---|
| Baseline | 1736 ± 863.0 | 1718 ± 784.5 |
| Month 4 (Mean change) | -206 ± 757 | -80 ± 743 |
| Month 9 (Mean change) | -155 ± 908 | -93 ± 763 |
Participants will self-report weight in pounds each time point
| weight in pounds (lbs) | Healthy Homes/Healthy Families (HH/HF) Intervention | Control |
|---|---|---|
| Baseline | 202.3 ± 53.1 | 204.1 ± 51.9 |
| Month 4 (Mean change from baseline ) | -6.5 ± 21.74 | -2.9 ± 19.31 |
| Month 9 (Mean change from baseline) | -4.5 ± 20.64 | -2.5 ± 21.17 |
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
| number of unhealthy snacks in the home | Healthy Homes/Healthy Families (HH/HF) Intervention | Control |
|---|---|---|
| Baseline | 4.29 ± 1.71 | 4.45 ± 1.72 |
| Month 4 | -1.12 ± 2.05 | -0.18 ± 1.90 |
| Month 9 | -0.75 ± 2.18 | -0.39 ± 2.10 |
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.
| percentage of participants | Healthy Homes/Healthy Families (HH/HF) Intervention | Control |
|---|---|---|
| Baseline | 76.19 | 72.37 |
| Month 4 | 10.8 | 4.7 |
| Month 9 | 7.2 | 5.5 |
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
| units on a scale | Healthy Homes/Healthy Families (HH/HF) Intervention | Control |
|---|---|---|
| Baseline | 2.10 ± 0.44 | 2.12 ± 0.45 |
| Month 4 (mean change from baseline) | 0.21 ± 0.49 | -0.02 ± 0.40 |
| Month 9 (mean change from baseline) | 0.20 ± 0.48 | 0.05 ± 0.40 |
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.
| meals per week | Healthy Homes/Healthy Families (HH/HF) Intervention | Control |
|---|---|---|
| Baseline | 3.27 ± 3.50 | 2.88 ± 2.94 |
| Month 4 (mean change from baseline) | -0.59 ± 3.59 | -0.12 ± 3.02 |
| Month 9 (mean change from baseline) | -0.67 ± 4.30 | -0.01 ± 3.44 |
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.
| units on a scale | Healthy Homes/Healthy Families (HH/HF) Intervention | Control |
|---|---|---|
| Baseline | 2.65 ± 1.02 | 2.58 ± 1.09 |
| Month 4 (mean change from baseline) | -0.55 ± 1.08 | -0.16 ± 1.03 |
| Month 9 (mean change from baseline) | -0.45 ± 1.10 | -0.17 ± 1.04 |
Collected over Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 12. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Homes/Healthy Families (HH/HF) Intervention | 0/253 (0%) | 0/253 (0%) | 0/253 (0%) |
| Control | 0/257 (0%) | 0/257 (0%) | 0/257 (0%) |
| Age, Continuous(years) | Healthy Homes/Healthy Families (HH/HF) Intervention | Control | Total |
|---|---|---|---|
| Mean | 43.8 ± 12.2 | 43.0 ± 11.7 | 43.4 ± 11.4 |
| Sex: Female, Male(Participants) | Healthy Homes/Healthy Families (HH/HF) Intervention | Control | Total |
|---|---|---|---|
| Female | 230 | 237 | 467 |
| Male | 23 | 20 | 43 |
| Ethnicity (NIH/OMB)(Participants) | Healthy Homes/Healthy Families (HH/HF) Intervention | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 7 | 10 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 250 | 250 | 500 |
| Race/Ethnicity, Customized(Participants) | Healthy Homes/Healthy Families (HH/HF) Intervention | Control | Total |
|---|---|---|---|
| Race — American Indian, Alaska Native Asian | 3 | 0 | 3 |
| Race — Native Hawaiian or Pacific Islander | 0 | 0 | 0 |
| Race — Black or African American | 206 | 210 | 416 |
| Race — White | 31 | 21 | 52 |
| Race — More than one race | 8 | 14 | 22 |
| Race — Unknown or not reported | 3 | 7 | 10 |
| Highest education(Participants) | Healthy Homes/Healthy Families (HH/HF) Intervention | Control | Total |
|---|---|---|---|
| Less than high school | 20 | 24 | 44 |
| High school or GED | 66 | 86 | 152 |
| Some college/technical school | 103 | 91 | 194 |
| College graduate or higher | 64 | 56 | 120 |
| Employment status(Participants) | Healthy Homes/Healthy Families (HH/HF) Intervention | Control | Total |
|---|---|---|---|
| Employed | 143 | 138 | 281 |
| Not Employed | 110 | 119 | 229 |
| Household income(Participants) | Healthy Homes/Healthy Families (HH/HF) Intervention | Control | Total |
|---|---|---|---|
| $10,000 and under | 66 | 70 | 136 |
| $10,001 - $20,000 | 57 | 67 | 124 |
| $20,001 - $35,000 | 55 | 67 | 122 |
| $35,001 - $50,000 | 35 | 27 | 62 |
| More than $50,000 | 28 | 15 | 43 |
| Marital status(Participants) | Healthy Homes/Healthy Families (HH/HF) Intervention | Control | Total |
|---|---|---|---|
| Married/living with partner | 63 | 49 | 112 |
| Widowed/separated/divorced | 62 | 56 | 118 |
| Not married | 128 | 152 | 280 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual participant data that underlie the results, after de-identification will be shared
Supporting information: Study protocol, Statistical analysis plan
Time frame: Six months after publication of the primary results data will become available
Access criteria: Researchers should send a methodologically sound proposal to mkegler@emory.edu. To gain access, requesters will need to sign a data access agreement. Upon approval, data will be shared via a secure website such as Box
Ran from Sep 2020 to primary completion in Aug 2023, 35 months.
Results were first posted in Oct 2025, 2 years 1 month after primary completion.
Of 90 non-industry interventional studies with no phase under Body Weight Changes, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 35 months is above that.
Counting every sponsor, half of 99 studies reached it within 12 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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