Last Verified: | December/31/2019 |
First Submitted: | January/20/2019 |
Estimated Enrollment Submitted: | April/14/2019 |
First Posted: | April/15/2019 |
Last Update Submitted: | January/16/2020 |
Last Update Posted: | January/20/2020 |
Actual Study Start Date: | August/28/2018 |
Estimated Primary Completion Date: | January/14/2021 |
Estimated Study Completion Date: | January/14/2021 |
Study Type: | Interventional |
Allocation: | Randomized |
: | Prospective Randomized |
Primary Purpose: | Treatment |
Masking: | None (Open Label) |
Arm | Intervention/treatment |
---|---|
Experimental: Traditional Treatment Participant receives recommendations for caloric intake, exercise and prescription for metformin if indicated | Drug: Traditional Treatment Traditional care including diet, exercise and metformin |
Other: One-On-One Low Starch Dietary Instruction Participant receives One-On-One Low Starch Dietary Instruction from Study Collaborator | Other: One-On-One Low Starch Dietary Instruction Participant receives one-on-one dietary counseling from study personnel |
Other: Low Starch Dietary Instruction by Video Participant receives Low Starch Dietary Instruction by Video Link | Other: Low Starch Dietary Instruction by Video Participant receives video dietary instruction |
Ages Eligible for Study: | 18 Years to 18 Years |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Criteria: | Inclusion Criteria: - Women ages 18-45 - BMI of >25 but < 45 - PCOS - Access to a computer/phone/electronic device with internet connection. Exclusion Criteria: - Pregnancy - Abnormal thyroid stimulating hormone (TSH) - Hyperprolactinemia - adrenal hyperplasia - Cushing's disease Ovarian and adrenal tumors. Previous diagnosis of diabetes. History of eating disorder History of surgical weight loss procedure Persons with an inability to give informed consent Persons unable/unwilling to exercise or to prepare their own food |