Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers

NCT ID: NCT04373434

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 512 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-18
• Study Completion Date: 2023-08-28

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.

Conditions

Weight Change, Body

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Health Homes/Healthy Families (HH/HF) Intervention

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: 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.

Interventions

Health Homes/Healthy Families (HH/HF) Intervention

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

Control

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Michelle C. Kegler

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle Kegler, DrPH/MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University, Rollins School of Public Health

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CDC-IRB00112359

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00112359

Identifier Type: -

Identifier Source: org_study_id