Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers
Primary Purpose
Weight Change, Body
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Homes/Healthy Families (HH/HF) Intervention
Control
Sponsored by
About this trial
This is an interventional prevention trial for Weight Change, Body focused on measuring Weight Gain Prevention, Cancer Prevention, Chronic Conditions, Obesity, Healthy Eating
Eligibility Criteria
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
Sites / Locations
- Emory University, Rollins School of Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Healthy Homes/Healthy Families (HH/HF) Intervention
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in United States Department of Agriculture (USDA) Healthy Eating Index (HEI)
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".
Secondary Outcome Measures
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.
Change in self-reported weight
Participants will self-report weight in pounds each time point
Changes to food environment
A home environment survey will be administered via telephone at each time point to assess household food inventory, food preparation methods, meals/snacks with the television on, use of non-home food sources for family meals, and frequency of shopping for fruits and vegetables.
Full Information
NCT ID
NCT04373434
First Posted
April 29, 2020
Last Updated
January 30, 2023
Sponsor
Emory University
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT04373434
Brief Title
Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers
Official Title
A Hybrid Effectiveness-Implementation Study on Weight Gain Prevention Among 2-1-1 Callers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 18, 2020 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Centers for Disease Control and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Change, Body
Keywords
Weight Gain Prevention, Cancer Prevention, Chronic Conditions, Obesity, Healthy Eating
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
504 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Homes/Healthy Families (HH/HF) Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Homes/Healthy Families (HH/HF) Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
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".
Time Frame
Baseline, Month 4, Month 9
Secondary Outcome Measure Information:
Title
Change in Kcal per day intake
Description
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
Title
Change in self-reported weight
Description
Participants will self-report weight in pounds each time point
Time Frame
Baseline, Month 4, Month 9
Title
Changes to food environment
Description
A home environment survey will be administered via telephone at each time point to assess household food inventory, food preparation methods, meals/snacks with the television on, use of non-home food sources for family meals, and frequency of shopping for fruits and vegetables.
Time Frame
Baseline, Month 4, Month 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Kegler, DrPH/MPH
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University, Rollins School of Public Health
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results, after de-identification will be shared
IPD Sharing Time Frame
Six months after publication of the primary results data will become available
IPD Sharing 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
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Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers
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