Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT03837405
Eligibility Criteria:
Inclusion Criteria:
1. History of T2DM mellitus.
2. HbA1c ≥ 6.5% and \< 12.0% at screening.
3. Experience food-related cravings most days of the week and eat in response to these cravings regularly.
4. Aged 18 years old and older.
5. Able to engage in light physical activity.
6. Willing and able to participate in the interventions including appropriate participation in the group setting.
7. Have smartphone and are willing to use it on a regular basis for data collection.
8. Ability to speak English.
Exclusion Criteria:
1. Unable to provide informed consent.
2. 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, that may need immediate changes in medical management that will affect study outcome measures, or that may require important adaptations in the study diet.
3. Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less than 6 months post-partum.
4. Current use of weight loss medications, such as Alli or amphetamine-based drugs that may affect weight.
5. Planned or history of weight-loss (bariatric) surgery, or other intestinal surgeries that cause malabsorption. These are likely to change study outcome measures, making it difficult to distinguish the effects of the intervention program, or require extensive tailoring of the diet intervention.
6. Currently enrolled in a weight loss program, such as Weight Watchers or a self-help group such as Overeaters Anonymous, or have unalterable plans to enroll in one of these programs in the next year; using a ketogenic low carbohydrate diet in the past 6 months with advice from a health care professional; or use of a mindful eating program with guidance from a professional in the past 6 months or have ever used the study mindful-eating app.
7. Vegan or vegetarian.
8. Unwilling to do regular blood testing at home for glucose or ketone monitoring.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03837405
Study Brief:
Protocol Section:
NCT03837405