MedPath

Digital Health Weight Management Among Public Housing Residents

Not Applicable
Active, not recruiting
Conditions
Obesity
Weight Change, Body
Interventions
Behavioral: mHealth
Behavioral: CHW support
Registration Number
NCT04852042
Lead Sponsor
Tufts Medical Center
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
348
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
mHealth GroupmHealth12 month text messaging program about diet and physical activity behavioral goals
mHealth+Community Health Worker (CHW) supportCHW supportsame as mHealth group + monthly behavioral phone counseling by a CHW
mHealth+Community Health Worker (CHW) supportmHealthsame as mHealth group + monthly behavioral phone counseling by a CHW
Primary Outcome Measures
NameTimeMethod
Change in Weight at 12-month follow upBaseline, 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
NameTimeMethod
Physical activity behaviorBaseline, 6-month follow up, 12-month follow up

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 variablesBaseline, 6-month follow up, 12-month follow up

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.

Diet behaviorBaseline, 6-month follow up, 12-month follow up

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.

Change in Weight at 6-month follow upBaseline, 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.

Trial Locations

Locations (1)

Boston Medical Center

🇺🇸

Boston, Massachusetts, United States

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