Examining the Effects of Diet on Health With an Online Program
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/21/2016 |
| Start Date: | October 2013 |
| End Date: | June 2015 |
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.
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.
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).
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 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.
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