Examining the Effects of Diet on Health With an Online Program

Type 2 Diabetes Clinical Trial

Official title:

Examining the Effects of Diet on Health With an Online Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967992
• Other study ID #: 13-11813
• Status: Completed
• Phase: Phase 2
• First received: October 18, 2013
• Last updated: October 12, 2015
• Start date: October 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study is a 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 programs to help people manage diabetes and lose weight, one using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA) and the other using on a low-carbohydrate diet (LC) and mindfulness and positive affect lifestyle modifications. Intervention content will include information about nutrition (American Diabetes Association recommended diet or carbohydrate restriction) and, in the LC group, emotion regulation, positive affect, and mindful eating strategies.

Description:

Approximately individuals with type 2 diabetes will be randomized in a 1:1 ratio to treatment groups. Classes will occur online. Participants will be evaluated at 0, 16, and 32 weeks. Our main outcome of interest is HbA1c (glycated hemoglobin, a measure indicative of blood glucose levels and tied to diabetes severity).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. HbA1c 6.5%-9% at screening.

2. Aged 18 years old and older

3. BMI 25 and above.

4. Willing and able to participate in the interventions such as having sufficient control over their food intake. Must have the ability to make choices about the food they eat; cannot have a lifestyle in which they eat out most of their meals.)

Exclusion Criteria:

1. Unable to provide informed consent.

2. Non English speaker.

3. No current use of insulin, no immediate plans to start or increase diabetic mediations, and no use of diabetes medications besides metformin.

4. A substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate in the intervention. Such conditions may include: cancer, liver failure, unstable coronary artery disease, severe emphysema, binge eating disorder or history of binge eating disorder, bulimia or strong history of bulimia.

5. Previous use or recent changes in medications that can interfere with the measures used in the study: current use of insulin; use of systemic (oral or IV) corticosteroids in the 6 months prior to enrollment or severe autoimmune disorders or other conditions (e.g. rheumatoid arthritis, lupus), that are likely to require these medications; and initiation of new class of psychiatric medications in past 2 months.

6. Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less than 6 months post-partum.

7. Current use of weight loss medications or supplements such as Alli or amphetamine-based drugs that are believed to have some effect on weight.

8. History of or planned weight loss surgery.

9. Vegan or vegetarian. The intervention diets are more challenging for vegan and vegetarian participants.

10. No or very limited internet access at a computer. Must be able to complete the online assessments and access the online class materials.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Behavioral:
• Behavioral: Low Carbohydrate, Ketogenic Diet

• American Diabetes Association Diet

• Mindfulness and Positive Affect Skills

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body weight	We will test whether body weight changes from pre-intervention to 16 weeks. The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 16 weeks.	baseline to 16 weeks	No
Other	Body weight	We will test whether body weight changes from pre-intervention to 32 weeks. The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 32 weeks.	baseline to 32 weeks	No
Primary	Hemoglobin A1c	We will test whether Hemoglobin A1c changes from pre-intervention to 16 weeks. The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 16 weeks.	baseline to 16 weeks	No
Secondary	Hemoglobin A1c	We will test whether Hemoglobin A1c changes from pre-intervention to 32 weeks. The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 32 weeks.	baseline to 32 weeks	No

External Links

•   recruitment website for study