NCT03677362

Brief Summary

The proposed single arm 6 mo. trial will assess the impact of weight loss and fat loss due to a multicomponent remotely-delivered lifestyle intervention on ovulation rates and time-to-ovulation in overweight and obese women with anovulatory infertility caused by PCOS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

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

September 10, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2020

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

1.5 years

First QC Date

September 13, 2018

Last Update Submit

August 31, 2020

Conditions

Polycystic Ovary SyndromeOverweight and Obesity

Outcome Measures

Primary Outcomes (1)

  • Ovulation

    Ovulation will be assessed weekly during the 6 mo. intervention by ovulation monitoring kit and the OvuSense device.

    6 months

Secondary Outcomes (2)

  • Fertility related quality of life

    Baseline and 6 months

  • Body composition

    Baseline and 6 months

Study Arms (1)

Weight loss intervention

EXPERIMENTAL

In the WLI, energy intake will be prescribed at 1200-1500 kcal/d using commercially available portion-controlled entrées, low calorie shakes, fruits/vegetables, and ad-libitum non-caloric beverages. Participants will be asked to consume a minimum daily total of 2 entrées (\~200 to 300 kcal each, saturated fat ≤ 3g), 3 shakes (\~100 kcal each), five 1-cup servings of fruits/vegetables, and ad libitum non-caloric beverages. Additionally, they will be asked to complete 225 min of moderate intensity PA, and self-monitor diet, PA (self-report) and body weight (home scale) across the 6 mo. intervention. Weekly behavioral counseling sessions (45 min) via Skype will be delivered by a professional health educator (HE) to participants in their homes.

Behavioral: Weight loss intervention

Interventions

Weight loss interventionBEHAVIORAL

In the WLI, energy intake will be prescribed at 1200-1500 kcal/d using commercially available portion-controlled entrées, low calorie shakes, fruits/vegetables, and ad-libitum non-caloric beverages. Participants will be asked to consume a minimum daily total of 2 entrées (\~200 to 300 kcal each, saturated fat ≤ 3g), 3 shakes (\~100 kcal each), five 1-cup servings of fruits/vegetables, and ad libitum non-caloric beverages. Additionally, they will be asked to complete 225 min of moderate intensity PA, and self-monitor diet, PA (self-report) and body weight (home scale) across the 6 mo. intervention. Weekly behavioral counseling sessions (45 min) via group phone callsSkype will be delivered by a professional health educator (HE) to participants in their homes.

Weight loss intervention

Eligibility Criteria

Age21 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Anovulatory infertility caused by Polycystic ovarian syndrome
  • Age 21 to 42.
  • Body mass index (BMI) \> 25 to 45 kg/m2.
  • Weight stable (± 4.6 kg) in previous 3 months
  • Willing to delay fertility treatment for 6 mos

You may not qualify if:

  • Unable to participate in moderate-vigorous physical activity (i.e., brisk walking)
  • Currently participating in greater than 3, 30-minute bouts of planned PA/week
  • Participation in a weight loss or PA program in the previous 6 mos.
  • Currently on a weight loss medication (wash out period 2 mos.)
  • Any other infertility diagnosis besides ovulatory dysfunction
  • Binge eating disorder as assessed by the Binge Eating Scale.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • Gorczyca AM, Steger FL, Ptomey LT, Montgomery RN, Mickelsen R, Smith P, Donnelly JE, Marsh CA. The impact of a group based, remotely delivered weight loss intervention in women with polycystic ovary syndrome on ovulation, quality of life and body composition. Front Reprod Health. 2022 Jul 22;4:940945. doi: 10.3389/frph.2022.940945. eCollection 2022.

    PMID: 36303658DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeOverweightObesity

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Courtney Marsh, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2018

First Posted

September 19, 2018

Study Start

September 10, 2018

Primary Completion

February 22, 2020

Study Completion

February 22, 2020

Last Updated

September 1, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)