Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDC-IRB00112359 | Other Identifier | Centers for Disease Control and Prevention |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Homes/Healthy Families (HH/HF) Intervention | Experimental | 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. |
|
| Control | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Homes/Healthy Families (HH/HF) Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Month 4, Month 9 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michelle Kegler, DrPH/MPH | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University, Rollins School of Public Health | Atlanta | Georgia | 30322 | United States |
Individual participant data that underlie the results, after de-identification will be shared
Six months after publication of the primary results data will become available
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
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 4, Month 9 |
|
Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 12
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle C. Kegler, MPH, DrPH | Emory University | 404-712-9957 | mkegler@emory.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2024 | Jul 29, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 17, 2023 | Feb 6, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D002908 | Chronic Disease |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
Not provided
Not provided
| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Control | Behavioral | 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. |
|
| Baseline, Month 4, Month 9 |
| Change in Self-reported Weight | Participants will self-report weight in pounds each time point | 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 | 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. | 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 | 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. | 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. | Baseline, Month 4, Month 9 |
| Refused at 4 months |
|
| Excluded |
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Some participants did not provide information for every baseline characteristic | Count of Participants | Participants |
|
| Highest education | Count of Participants | Participants |
|
| Employment status | Count of Participants | Participants |
|
| Household income | Some participants did not provide information for every baseline characteristic. | Count of Participants | Participants |
|
| Marital status | Count of Participants | 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.
| OG001 | 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 |
|
|
| Secondary | 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. | Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above. | Posted | Mean | Standard Deviation | Kcal/day | Baseline, Month 4, Month 9 |
|
|
|
| Secondary | Change in Self-reported Weight | Participants will self-report weight in pounds each time point | Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above | Posted | Mean | Standard Deviation | weight in pounds (lbs) | Baseline, Month 4, Month 9 |
|
|
|
| Secondary | 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 | Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above | Posted | Mean | Standard Deviation | number of unhealthy snacks in the home | Baseline, Month 4, Month 9 |
|
|
|
| Secondary | 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. | Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above | Posted | Number | percentage of participants | Baseline, Month 4, Month 9 |
|
|
|
| Secondary | 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 | Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 4, Month 9 |
|
|
|
| Secondary | 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. | Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above | Posted | Mean | Standard Deviation | meals per week | Baseline, Month 4, Month 9 |
|
|
|
| Secondary | 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. | Some participants were lost to follow-up. For the exact breakdown, kindly refer to the baseline characteristics above | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 4, Month 9 |
|
|
|
| 0 |
| 253 |
| 0 |
| 253 |
| 0 |
| 253 |
| EG001 | 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 | 0 | 257 | 0 | 257 | 0 | 257 |
Not provided
Not provided
Not provided
| D010335 | Pathologic Processes |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| Unknown or Not Reported |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or not reported |
|
| Some college/technical school |
|
| College graduate or higher |
|
| $20,001 - $35,000 |
|
| $35,001 - $50,000 |
|
| More than $50,000 |
|
| Month 4 (Mean change) |
|
|
| Month 9 (Mean change) |
|
|
| Month 4 (Mean change from baseline ) |
|
|
| Month 9 (Mean change from baseline) |
|
|
| Month 4 |
|
|
| Month 9 |
|
|
| Month 4 |
|
|
| Month 9 |
|
|
| Month 4 (mean change from baseline) |
|
|
| Month 9 (mean change from baseline) |
|
|
| Month 4 (mean change from baseline) |
|
|
| Month 9 (mean change from baseline) |
|
|
| Month 4 (mean change from baseline) |
|
|
| Month 9 (mean change from baseline) |
|
|