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Completed

NCT Number: NCT01967992

Examining the Effects of Diet on Health With an Online Program

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.

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California, San Francisco

San Francisco, California, 94115, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HbA1c 6.5%-9% at screening.
  • Aged 18 years old and older
  • BMI 25 and above.
  • 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

  • Unable to provide informed consent.
  • Non English speaker.
  • No current use of insulin, no immediate plans to start or increase diabetic mediations, and no use of diabetes medications besides metformin.
  • 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.
  • 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.
  • Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less than 6 months post-partum.
  • Current use of weight loss medications or supplements such as Alli or amphetamine-based drugs that are believed to have some effect on weight.
  • History of or planned weight loss surgery.
  • Vegan or vegetarian. The intervention diets are more challenging for vegan and vegetarian participants.
  • No or very limited internet access at a computer. Must be able to complete the online assessments and access the online class materials.

Treatment and study plan

Behavioral: Low Carbohydrate, Ketogenic Diet

Behavioral

American Diabetes Association Diet

Behavioral

Mindfulness and Positive Affect Skills

Behavioral

Primary outcomes

  1. Hemoglobin A1c

    Time frame: baseline to 16 weeks

    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.

Secondary outcomes

  1. Hemoglobin A1c

    Time frame: baseline to 32 weeks

    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.

Other outcomes

  1. Body weight

    Time frame: baseline to 16 weeks

    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.

  2. Body weight

    Time frame: baseline to 32 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 23, 2013
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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