Recruitment

Recruitment Status
Completed
Estimated Enrollment
100

Inclusion Criterias

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

Exclusion Criterias

History of or planned weight loss surgery.
Vegan or vegetarian. The intervention diets are more challenging for vegan and vegetarian participants.
Non English speaker.
...
History of or planned weight loss surgery.
Vegan or vegetarian. The intervention diets are more challenging for vegan and vegetarian participants.
Non English speaker.
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.
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.
No or very limited internet access at a computer. Must be able to complete the online assessments and access the online class materials.
No current use of insulin, no immediate plans to start or increase diabetic mediations, and no use of diabetes medications besides metformin.
Unable to provide informed consent.
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.

Summary

Conditions
Type 2 Diabetes
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 100 years
Gender
Both males and females

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...

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).

Inclusion Criterias

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

Exclusion Criterias

History of or planned weight loss surgery.
Vegan or vegetarian. The intervention diets are more challenging for vegan and vegetarian participants.
Non English speaker.
...
History of or planned weight loss surgery.
Vegan or vegetarian. The intervention diets are more challenging for vegan and vegetarian participants.
Non English speaker.
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.
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.
No or very limited internet access at a computer. Must be able to complete the online assessments and access the online class materials.
No current use of insulin, no immediate plans to start or increase diabetic mediations, and no use of diabetes medications besides metformin.
Unable to provide informed consent.
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.

Locations

San Francisco, California, 94115
San Francisco, California, 94115

Tracking Information

NCT #
NCT01967992
Collaborators
Not Provided
Investigators
  • Principal Investigator: Laura R Saslow, PhD University of Michigan Principal Investigator: Rick Hecht, MD University of California, San Francisco
  • Laura R Saslow, PhD University of Michigan Principal Investigator: Rick Hecht, MD University of California, San Francisco