Clinical trial NCT04852042: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Weight Change, Body
Obesity
Keywords: Community health workers
Public housing residents
Behavioral interventions
Healthy eating
Physical activity
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2021-04-21
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in Weight at 12-month follow up
timeFrame: Baseline, 12-month follow up
Secondary outcomes:
measure: Change in Weight at 6-month follow up
timeFrame: Baseline, 6-month follow up
measure: Diet behavior
timeFrame: Baseline, 6-month follow up, 12-month follow up
measure: Physical activity behavior
timeFrame: Baseline, 6-month follow up, 12-month follow up
measure: Psycho-social variables
timeFrame: Baseline, 6-month follow up, 12-month follow up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Lisa Quintiliani, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: BU School of Public Health, Community Health Services
name: Ziming Xuan, ScD
role: PRINCIPAL_INVESTIGATOR
References:
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.