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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04373434

Enrollment

512

Registered

2020-05-04

Start date

2020-09-18

Completion date

2023-08-28

Last updated

2025-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Change, Body

Keywords

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

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.

Interventions

BEHAVIORALHealth 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.

BEHAVIORALControl

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in United States Department of Agriculture (USDA) Healthy Eating Index (HEI)	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).

Secondary

Measure	Time frame	Description
Change in Self-reported Weight	Baseline, Month 4, Month 9	Participants will self-report weight in pounds each time point
Changes to Food Environment: UNHEALTHY SNACKS/FOODS INVENTORY, OF 8	Baseline, Month 4, Month 9	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
Changes to Food Environment: PURCHASING FRUITS/VEGETABLES ≥1/WK	Baseline, Month 4, Month 9	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.
Change in Kcal Per Day Intake	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.
Changes to Food Environment: FAMILY MEALS FROM NONHOME SOURCES, DAYS IN PAST WEEK	Baseline, Month 4, Month 9	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.
Changes to Food Environment: Family Eating and TV	Baseline, Month 4, Month 9	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.
Changes to Food Environment: HEALTHY FOOD PREPARATION	Baseline, Month 4, Month 9	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

Countries

United States

Participant flow

Recruitment details

Participants were recruited from the United Way of Greater Atlanta 2-1-1, United Way of Central Georgia, United Way of the Chattahoochee Valley 2-1-1, and United Way of Southwest Georgia as part of a hybrid effectiveness implementation trial testing an adapted version of the Healthy Homes/Healthy Families healthy eating and weight gain prevention intervention. Participant enrollment began in September 2020, and final follow-up assessments were completed in December 2022.

Participants by arm

Arm	Count
Healthy Homes/Healthy Families (HH/HF) Intervention Received a 12-week telephone-based healthy eating and weight gain prevention intervention, Healthy Homes/Healthy Families, that supports households in making changes in their home environment to promote healthy eating.	253
Control Received two mailings post baseline: first mailing included a food diary from the CDC, and healthy eating information from the Dietary Guidelines for Americans 2015-2020; Second mailing included the food diary and healthy eating information from Choose MyPlate	257
Total	510

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Excluded	2	0
Overall Study	Lost to Follow-up	37	32
Overall Study	Refused at 4 months	7	3
Overall Study	Refused at 9 months	1	2

Baseline characteristics

Characteristic	Control	Healthy Homes/Healthy Families (HH/HF) Intervention	Total
Age, Continuous	43.0 years STANDARD_DEVIATION 11.7	43.8 years STANDARD_DEVIATION 12.2	43.4 years STANDARD_DEVIATION 11.4
Employment status Employed	138 Participants	143 Participants	281 Participants
Employment status Not Employed	119 Participants	110 Participants	229 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants	3 Participants	10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	250 Participants	250 Participants	500 Participants
Highest education College graduate or higher	56 Participants	64 Participants	120 Participants
Highest education High school or GED	86 Participants	66 Participants	152 Participants
Highest education Less than high school	24 Participants	20 Participants	44 Participants
Highest education Some college/technical school	91 Participants	103 Participants	194 Participants
Household income $10,000 and under	70 Participants	66 Participants	136 Participants
Household income $10,001 - $20,000	67 Participants	57 Participants	124 Participants
Household income $20,001 - $35,000	67 Participants	55 Participants	122 Participants
Household income $35,001 - $50,000	27 Participants	35 Participants	62 Participants
Household income More than $50,000	15 Participants	28 Participants	43 Participants
Marital status Married/living with partner	49 Participants	63 Participants	112 Participants
Marital status Not married	152 Participants	128 Participants	280 Participants
Marital status Widowed/separated/divorced	56 Participants	62 Participants	118 Participants
Race/Ethnicity, Customized Race American Indian, Alaska Native Asian	0 Participants	3 Participants	3 Participants
Race/Ethnicity, Customized Race Black or African American	210 Participants	206 Participants	416 Participants
Race/Ethnicity, Customized Race More than one race	14 Participants	8 Participants	22 Participants
Race/Ethnicity, Customized Race Native Hawaiian or Pacific Islander	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race Unknown or not reported	7 Participants	3 Participants	10 Participants
Race/Ethnicity, Customized Race White	21 Participants	31 Participants	52 Participants
Sex: Female, Male Female	237 Participants	230 Participants	467 Participants
Sex: Female, Male Male	20 Participants	23 Participants	43 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 253	0 / 257
other Total, other adverse events	0 / 253	0 / 257
serious Total, serious adverse events	0 / 253	0 / 257

Outcome results

Primary

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).