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Digital Health Weight Management Among Public Housing Residents

Primary Purpose

Weight Change, Body, Obesity

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

mHealth

CHW support

About this trial

This is an interventional prevention trial for Weight Change, Body focused on measuring Community health workers, Public housing residents, Behavioral interventions, Healthy eating, Physical activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Current resident of Boston public housing development
No plans to move within the next 6 months and no plan on leaving the country for more than 2 months over the next year
Able to read and speak in English or Spanish
Has cell phone with a plan that allows for unlimited text messages
Willing to wear a device to track physical activity during assessment periods

Exclusion Criteria:

Currently enrolled in a comprehensive weight loss program or a research study about weight that is incompatible with study participation
Currently on a medically prescribed diet or fast that is incompatible with study participation
Currently has a diagnosis of bipolar disorder, mania, manic-depressive disorder, schizophrenia, or psychosis and is not on any medications to treat the condition
Precontemplation stage of change for making healthy eating or physical activity changes
Pregnancy
Medical contraindications to physical activity. Self-reported presence of any of the following:
- Can not walk without help from someone else
- Regularly needs to use the following special equipment to walk or get around: wheelchair, scooter, walker, or extra oxygen
- Gets short of breath even when using special equipment at a very low level of physical activity such as walking around the home, making a bed, or taking a bath
- Advised by a healthcare professional not to exercise and or if diagnosed with a bone or joint problem, it could get worse.
- Frequently gets pains in the heart or chest
- Had a heart attack in the past 6 months
- Often feels faint or has spells of severe dizziness
- Has very high blood pressure that is often over 175 or the bottom blood pressure number is often over 110
- Has a good physical reason not to follow an activity program even if they wanted to

Sites / Locations

Boston Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

mHealth Group

mHealth+Community Health Worker (CHW) support

Control group

Arm Description

12 month text messaging program about diet and physical activity behavioral goals

same as mHealth group + monthly behavioral phone counseling by a CHW

Assessments only

Outcomes

Primary Outcome Measures

Change in Weight at 12-month follow up

Weight will be objectively measured by study staff using standard procedures using an accurate electronic scale designed for portable use measured to the nearest 1/10th reading.

Secondary Outcome Measures

Change in Weight at 6-month follow up

Weight will be objectively measured by study staff using standard procedures using an accurate electronic scale designed for portable use measured to the nearest 1/10th reading.

Diet behavior

Diet (for example: fruits & vegetables, whole grains, lean meats, and sugary beverages) will be measured via unannounced 24-hour recalls, one per person per assessment period. Other diet behaviors (for example: breakfast consumption) will be measured via questions on standardized surveys.

Physical activity behavior

Physical activity will be objectively measured via Actigraph 3tx accelerometers worn by participants for 7 days (minimum of 4 days) to assess time spent in light-to-moderate-to-vigorous physical activity.

Psycho-social variables

Psycho-social variables (for example: Self-efficacy, motivation, outcome expectations, depressive symptoms, sleep, social support) will be evaluated for change over the intervention period and whether they moderate the intervention effect on weight.

Full Information

NCT ID

NCT04852042

First Posted

April 16, 2021

Last Updated

August 21, 2023

Sponsor

Tufts Medical Center

Collaborators

National Institutes of Health (NIH), National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04852042

Brief Title

Digital Health Weight Management Among Public Housing Residents

Official Title

Digital Health Supported Weight Management Intervention Delivered by Community Health Workers Among Public Housing Residents

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 28, 2021 (Actual)

Primary Completion Date

February 2025 (Anticipated)

Study Completion Date

February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tufts Medical Center

Collaborators

National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This research will test the efficacy of a weight management intervention through a three-group randomized trial: mHealth only, mHealth+Community Health Worker (CHW) support, versus control group, among residents of Boston's public housing developments. The mHealth group consists of a 1-year text messaging program to promote diet and physical activity behavior changes and the CHW support consists of monthly phone counseling delivered by a CHW to support the text messaging program. Our hypothesis is that the mHealth+CHW group will be more effective in bringing about weight loss compared to mHealth alone or the assessment only control group. The findings are expected to inform future health promotion efforts among residents in public housing developments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Change, Body, Obesity

Keywords

Community health workers, Public housing residents, Behavioral interventions, Healthy eating, Physical activity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

515 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mHealth Group

Arm Type

Experimental

Arm Description

12 month text messaging program about diet and physical activity behavioral goals

Arm Title

mHealth+Community Health Worker (CHW) support

Arm Type

Experimental

Arm Description

same as mHealth group + monthly behavioral phone counseling by a CHW

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Assessments only

Intervention Type

Behavioral

Intervention Name(s)

mHealth

Intervention Description

Participants will receive 2-3 text messages daily. The messages will include information to promote healthy eating and physical activity.

Intervention Type

Behavioral

Intervention Name(s)

CHW support

Intervention Description

The CHW will provide behavioral counseling to participants guided by a study website related to their healthy eating and physical activity goals.

Primary Outcome Measure Information:

Title

Change in Weight at 12-month follow up

Description

Weight will be objectively measured by study staff using standard procedures using an accurate electronic scale designed for portable use measured to the nearest 1/10th reading.

Time Frame

Baseline, 12-month follow up

Secondary Outcome Measure Information:

Title

Change in Weight at 6-month follow up

Description

Weight will be objectively measured by study staff using standard procedures using an accurate electronic scale designed for portable use measured to the nearest 1/10th reading.

Time Frame

Baseline, 6-month follow up

Title

Diet behavior

Description

Time Frame

Baseline, 6-month follow up, 12-month follow up

Title

Physical activity behavior

Description

Time Frame

Baseline, 6-month follow up, 12-month follow up

Title

Psycho-social variables

Description

Time Frame

Baseline, 6-month follow up, 12-month follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Current resident of Boston public housing development No plans to move within the next 6 months and no plan on leaving the country for more than 2 months over the next year Able to read and speak in English or Spanish Has cell phone with a plan that allows for unlimited text messages Willing to wear a device to track physical activity during assessment periods Exclusion Criteria: Currently enrolled in a comprehensive weight loss program or a research study about weight that is incompatible with study participation Currently on a medically prescribed diet or fast that is incompatible with study participation Currently has a diagnosis of bipolar disorder, mania, manic-depressive disorder, schizophrenia, or psychosis and is not on any medications to treat the condition Precontemplation stage of change for making healthy eating or physical activity changes Pregnancy Medical contraindications to physical activity. Self-reported presence of any of the following: Can not walk without help from someone else Regularly needs to use the following special equipment to walk or get around: wheelchair, scooter, walker, or extra oxygen Gets short of breath even when using special equipment at a very low level of physical activity such as walking around the home, making a bed, or taking a bath Advised by a healthcare professional not to exercise and or if diagnosed with a bone or joint problem, it could get worse. Frequently gets pains in the heart or chest Had a heart attack in the past 6 months Often feels faint or has spells of severe dizziness Has very high blood pressure that is often over 175 or the bottom blood pressure number is often over 110 Has a good physical reason not to follow an activity program even if they wanted to

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ziming Xuan, ScD

Phone

617-638-4118

zxuan@bu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Annette Nansubug, MS

Phone

617-414-6673

annette.nansubuga@bmc.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lisa Quintiliani, PhD

Organizational Affiliation

Tufts Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ziming Xuan, ScD

Organizational Affiliation

BU School of Public Health, Community Health Services

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ziming Xuan, ScD

Phone

617-638-4118

zxuan@bu.edu

First Name & Middle Initial & Last Name & Degree

Annette Nansuburg, MS

Phone

617-414-6673

annette.nansuburg@bmc.org

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35724842

Citation

Solar C, Nansubuga A, Murillo J, Ranker L, Borrelli B, Bowen DJ, Xuan Z, Kane J, Werntz S, Crouter SE, Quintiliani LM. Mobile health plus community health worker support for weight management among public housing residents (Path to Health): A randomized controlled trial protocol. Contemp Clin Trials. 2022 Aug;119:106836. doi: 10.1016/j.cct.2022.106836. Epub 2022 Jun 18.

Results Reference

derived

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Digital Health Weight Management Among Public Housing Residents

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