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

NCT04373434 | Completed Results DMC

• 2 other identifiers: IRB00112359CDC-IRB00112359
• Study Type: interventional
• Target: 512
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will evaluate a healthy eating and weight gain prevention intervention for delivery through calls to the 2-1-1 number.

Conditions

Weight Change, Body

Keywords

Weight Gain Prevention; Cancer Prevention; Chronic Conditions; Obesity; Healthy Eating

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Change in Kcal Per Day Intake

  Baseline, Month 4, Month 9

• Change in Self-reported Weight

  Baseline, Month 4, Month 9

• Changes to Food Environment: UNHEALTHY SNACKS/FOODS INVENTORY, OF 8

  Baseline, Month 4, Month 9

• Changes to Food Environment: PURCHASING FRUITS/VEGETABLES ≥1/WK

  Baseline, Month 4, Month 9

• Changes to Food Environment: HEALTHY FOOD PREPARATION

  Baseline, Month 4, Month 9

Study Arms (2)

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.

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.

Behavioral: Control

Interventions

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.

Healthy Homes/Healthy Families (HH/HF) Intervention

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.

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 70 years of age
• able to speak English
• self-report BMI of 20 and above

You may not qualify if:

• pregnant women
• only one member per household will be enrolled

Sponsors & Collaborators

• Emory University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Emory University, Rollins School of Public Health

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Body Weight Changes; Chronic Disease; Obesity

Interventions

Methods

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Michelle C. Kegler, MPH, DrPH
• Organization: Emory University

mkegler@emory.edu

404-712-9957

Study Officials

• Michelle Kegler, DrPH/MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 4, 2020
• Study Start: September 18, 2020
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: October 22, 2025
• Results First Posted: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Six months after publication of the primary results data will become available
• 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

Locations

US (1)