Low Starch Dietary Education Program vs. Traditional Treatment for PCOS
Compare Weight Loss and Metabolic Improvements Using a Low Starch Dietary Education Program vs. Traditional Treatment for Polycystic Ovary Syndrome (PCOS)
1 other identifier
interventional
71
1 country
1
Brief Summary
Compare weight loss and metabolic parameters in patients using a low starch dietary education program vs. traditional treatment (i.e., prescribing metformin, low calorie diet and exercise) for health improvement in women with PCOS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2018
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 29, 2018
CompletedFirst Submitted
Initial submission to the registry
January 21, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedAugust 7, 2023
August 1, 2023
4.1 years
January 21, 2019
August 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Weight
Weight
8 weeks
BMI
BMI
8 weeks
Secondary Outcomes (6)
waist to hip ratio
8 weeks
fasting glucose
8 weeks
fasting insulin
8 weeks
cholesterol
8 weeks
testosterone
8 weeks
- +1 more secondary outcomes
Study Arms (3)
Traditional Treatment
EXPERIMENTALParticipant receives recommendations for caloric intake, exercise and prescription for metformin if indicated
One-On-One Low Starch Dietary Instruction
OTHERParticipant receives One-On-One Low Starch Dietary Instruction from Study Collaborator
Low Starch Dietary Instruction by Video
OTHERParticipant receives Low Starch Dietary Instruction by Video Link
Interventions
Traditional care including diet, exercise and metformin
Participant receives one-on-one dietary counseling from study personnel
Participant receives video dietary instruction
Eligibility Criteria
You may qualify if:
- Women ages 18-45
- BMI of \>25 but \< 45
- PCOS
- Access to a computer/phone/electronic device with internet connection.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Tech Health Science Center
Lubbock, Texas, 79430, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer L Phy, DO
Texas Tech University Health Sciences Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2019
First Posted
April 16, 2019
Study Start
August 29, 2018
Primary Completion
October 10, 2022
Study Completion
December 31, 2022
Last Updated
August 7, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 2 years
- Access Criteria
- 2 years
Will post to Clinical Trials