- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04373434
Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers
A Hybrid Effectiveness-Implementation Study on Weight Gain Prevention Among 2-1-1 Callers
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University, Rollins School of Public Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 to 70 years of age
- able to speak English
- self-report BMI of 20 and above
Exclusion Criteria:
- pregnant women
- only one member per household will be enrolled
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy Homes/Healthy Families (HH/HF) Intervention
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.
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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.
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Active Comparator: Control
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in United States Department of Agriculture (USDA) Healthy Eating Index (HEI)
Time Frame: Baseline, Month 4, Month 9
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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).
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Baseline, Month 4, Month 9
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Kcal Per Day Intake
Time Frame: Baseline, Month 4, Month 9
|
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.
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Baseline, Month 4, Month 9
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Change in Self-reported Weight
Time Frame: Baseline, Month 4, Month 9
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Participants will self-report weight in pounds each time point
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Baseline, Month 4, Month 9
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Changes to Food Environment: UNHEALTHY SNACKS/FOODS INVENTORY, OF 8
Time Frame: Baseline, Month 4, Month 9
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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
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Baseline, Month 4, Month 9
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Changes to Food Environment: PURCHASING FRUITS/VEGETABLES ≥1/WK
Time Frame: Baseline, Month 4, Month 9
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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.
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Baseline, Month 4, Month 9
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Changes to Food Environment: HEALTHY FOOD PREPARATION
Time Frame: Baseline, Month 4, Month 9
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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
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Baseline, Month 4, Month 9
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Changes to Food Environment: FAMILY MEALS FROM NONHOME SOURCES, DAYS IN PAST WEEK
Time Frame: Baseline, Month 4, Month 9
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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.
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Baseline, Month 4, Month 9
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Changes to Food Environment: Family Eating and TV
Time Frame: Baseline, Month 4, Month 9
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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.
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Baseline, Month 4, Month 9
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michelle Kegler, DrPH/MPH, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00112359
- CDC-IRB00112359 (Other Identifier: Centers for Disease Control and Prevention)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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