A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics

Study on Type 2 Diabetes Management

Enrolling By Invitation
All
Fase N/A
1 Location

Brief description of study

The study is a small pilot, designed to provide data regarding the feasibility and acceptability of conducting such a study on a larger scale. The present study is a randomized controlled clinical trial comparing two mindfulness-based lifestyle modification programs to help people manage diabetes and lose weight, one using on a low-carbohydrate diet (LC) and the other using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA). Intervention content will include information about nutrition (carbohydrate restriction or American Diabetes Association recommended diet) and emotion regulation and mindful eating strategies.
 

Detailed description of study

Approximately 40 individuals with Type II diabetes or prediabetes will be randomized in a 1:1 ratio to treatment groups. Groups will meet for 12 weekly sessions, then approximately biweekly for 3 sessions, for a total of 15 1.5-2 hour sessions over 4.5 months. Participants will be evaluated at 0, 1 month, 3 months, and 6 months. Our outcome of interest is HbA1c (glycated hemoglobin, a measure indicative of blood glucose levels and tied to diabetes severity).
 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: diabetes, acne
  • Gender: All

Inclusion Criteria:
  • Diabetes mellitus, Type 2.
  • HgbA1c > 6.0% at screening. This is to confirm the diabetes diagnosis.
  • Aged 18 years old and older
  • BMI 25 and above.
Exclusion Criteria:
  • Condition that will make it difficult for participation. Such as:
    • cancer
    • liver failure
    • unstable coronary artery disease
    • severe emphysema
    • bulimia or strong history of bulimia
    • vegan
  • Laboratory evidence of organ dysfunction
    • Abnormal kidney function (serum creatinine)
    • thyroid stimulating hormone out of normal range
  • Previous use or new changes in medications that can interfere with the measures used in the study:
    • current use of insulin and no immediate plans to start or increase diabetic mediations.
    • more than 3 oral hypoglycemic medications.
    • use of systemic (oral or IV) corticosteroids in the 6 months prior
    • severe autoimmune disorders
    • initiation of psychiatric medications in past 2 months.
  • Weight loss confounds
    • Current use of weight loss medications or supplements.
    • History of or planned weight loss surgery.
  • Other
    • Pregnant or planning to get pregnant in the next year, breastfeeding, less than 6 months post-partum.
    • Unable or unwilling to do home glucose monitoring.
 

Updated on 11 Apr 2025. Study ID: NCT01713764

This study investigates ways to help people with Type II diabetes or prediabetes manage their condition and lose weight. It looks at two different lifestyle programs that include mindfulness and diet changes.

Participants will be divided into two groups. One group will follow a low-carbohydrate diet, while the other will follow a diet recommended by the American Diabetes Association. Both groups will learn about nutrition and strategies to help with eating and emotions. The study will last about 4.5 months, with 15 sessions that are 1.5 to 2 hours long.

  • Who can participate: Adults aged 18 and older with Type II diabetes or prediabetes can join. Participants should have a BMI of 25 or higher and an HbA1c level over 6.0%
  • Study details: The study involves two groups with different diet plans and mindfulness training. Participants will meet for 15 sessions over 4.5 months. HbA1c levels, which show blood sugar control, will be measured throughout the study
  • Study Timelines and Visits: The study will last about 4.5 months.The study requires about 15 visits
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