Health TrialsbyHealthPanel

Medically Intensive Nutrition Therapy Program for Obesity and Diabetes in a Low-income Population

ConditionsOverweightPreDiabetesDiabetes Type 2Obesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMassachusetts General Hospital

About this trial

This study is being done to better understand whether meal replacements can be an effective tool for weight loss and treatment of elevated blood sugars in people with obesity/overweight and diabetes/pre-diabetes who have a low income.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-65

Body mass index (BMI) greater than or equal to 27 kg/m²

HgA1C greater than or equal to 5.7 percent or fasting glucose greater than or equal to 100mg/dL within the previous 6 months

Low-income as defined by having a family income at or below 400 percent of the federal poverty level guidelines for 2022

Disqualifiers

Current use of antihyperglycemic agents (other than metformin) or approved anti- obesity medications or plans to start such regimens over the 3 months post-study enrollment

HbA1c greater than or equal to 10 percent

Plans to pursue bariatric surgery over the 6 months post-study enrollment

Weight loss of greater than 5 kg within the previous 3 months

Trial population

Adults with overweight or obesity and pre-diabetes or diabetes and low income

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Bariatrix Meal Replacement Products

    Dietary supplement

    Meal replacement products offered through the Massachusetts General Hospital Weight Center.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Adults with overweight/obesity and pre-diabetes/diabetes and low income1 intervention

Trial outcomes

Primary outcomes

1

Body weight reduction

Reduction in body weight by greater than or equal to 5 percent

Time frame
3 months
2

Hemoglobin A1c reduction

Reduction of Hemoglobin A1c by greater than or equal to 0.5 percent

Time frame
3 months

Secondary outcomes

1

Program adherence

Adherence with the program, and potential reasons for non-adherence as assessed with bi-weekly questionnaires

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov
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