Weight Change, BodyNCT04373434
Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers
A study testing Health Homes/Healthy Families (HH/HF) Intervention in people with Weight Change, Body, run by Emory University at 1 site in United States.
Trial summary
This trial will evaluate a healthy eating and weight gain prevention intervention for delivery through calls to the 2-1-1 number. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Weight Change, Body
- What is being tested?
- Health Homes/Healthy Families (HH/HF) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2020to 28 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years of age
- able to speak English
- self-report BMI of 20 and above
Who cannot join
- pregnant women
- only one member per household will be enrolled
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University, Rollins School of Public Health
Atlanta, Georgia, 30322
About this study
Official title: A Hybrid Effectiveness-Implementation Study on Weight Gain Prevention Among 2-1-1 Callers
This trial will evaluate a healthy eating and weight gain prevention intervention for delivery through calls to the 2-1-1 number.
Read the detailed description
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.
- Conditions
- Weight Change, Body
- Being tested
- Health Homes/Healthy Families (HH/HF) Intervention, Control
- Keywords
- Weight Gain Prevention, Cancer Prevention, Chronic Conditions, Obesity, Healthy Eating
- Medical subject headings
- Body Weight Changes, Chronic Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Homes/Healthy Families (HH/HF) InterventionBehavioural
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Health Homes/Healthy Families (HH/HF) Intervention |
| 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Month 4, Month 9
Secondary outcomes (7)
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.
Measured: Baseline, Month 4, Month 9
Change in Self-reported Weight
Participants will self-report weight in pounds each time point
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline, Month 4, Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start18 Sep 2020
- Primary completion28 Aug 2023
- Study completion28 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Weight Change, BodyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Michelle C. Kegler, Emory University
- Investigators
- Michelle Kegler, DrPH/MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373434
- Sponsor's protocol ID
- IRB00112359
- Other IDs
- CDC-IRB00112359
- Status last verified
- Oct 2025
- First submitted
- 29 Apr 2020
- Last updated
- 22 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results, after de-identification will be shared
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Effectiveness-Implementation Study on Weight Gain Prevention Among 2-1-1 Callers
- ClinicalTrials.gov ID
- NCT04373434
- Acronym / sponsor ID
- IRB00112359
- Conditions
- Weight Change, Body
- Keywords
- Weight Gain Prevention, Cancer Prevention, Chronic Conditions, Obesity, Healthy Eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Posted 22 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will evaluate a healthy eating and weight gain prevention intervention for delivery through calls to the 2-1-1 number.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Homes/Healthy Families (HH/HF) Intervention | Experimental | Behavioral: Health Homes/Healthy Families (HH/HF) InterventionParticipants 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 | Behavioral: ControlParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 70 years of age
- able to speak English
- self-report BMI of 20 and above
Key exclusion criteria (2 listed)
- pregnant women
- only one member per household will be enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Homes/Healthy Families (HH/HF) InterventionThe 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. | Behavioural | Healthy Homes/Healthy Families (HH/HF) Intervention |
| ControlParticipants 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. | Behavioural | Control |
Primary outcome
Change in United States Department of Agriculture (USDA) Healthy Eating Index (HEI)
Time frame: Baseline, Month 4, Month 9
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).
7 secondary outcomes
Change in Kcal Per Day Intake
Time frame: Baseline, Month 4, Month 9
Change in Self-reported Weight
Time frame: Baseline, Month 4, Month 9
Changes to Food Environment: UNHEALTHY SNACKS/FOODS INVENTORY, OF 8
Time frame: Baseline, Month 4, Month 9
Changes to Food Environment: PURCHASING FRUITS/VEGETABLES ≥1/WK
Time frame: Baseline, Month 4, Month 9
Changes to Food Environment: HEALTHY FOOD PREPARATION
Time frame: Baseline, Month 4, Month 9
Changes to Food Environment: FAMILY MEALS FROM NONHOME SOURCES, DAYS IN PAST WEEK
Time frame: Baseline, Month 4, Month 9
Changes to Food Environment: Family Eating and TV
Time frame: Baseline, Month 4, Month 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results, after de-identification will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Kegler, DrPH/MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Homes/Healthy Families (HH/HF) Intervention in people with Weight Change, Body, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in United States Department of Agriculture (USDA) Healthy Eating Index (HEI) (time frame: Baseline, Month 4, Month 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.