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Examining the Effects of Diet on Health With an Online Program | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Examining the Effects of Diet on Health With an Online Program

NCT01967992•University of California, San Francisco

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.

Detailed 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).

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Key Dates

Start Date

October 1, 2013

Primary Completion Date

June 1, 2015

Completion Date

June 1, 2015

Last Updated

October 14, 2015

Enrollment

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

Behavioral: Low Carbohydrate, Ketogenic Diet

BEHAVIORAL

American Diabetes Association Diet

BEHAVIORAL

Mindfulness and Positive Affect Skills

BEHAVIORAL

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 14, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Examining the Effects of Diet on Health With an Online Program

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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