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Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility (FIT-PLESE)

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ClinicalTrials.gov Identifier: NCT02432209
Recruitment Status : Completed
First Posted : May 4, 2015
Results First Posted : March 15, 2021
Last Update Posted : March 15, 2021
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Penn State University
Augusta University
University of California, San Francisco
University of North Carolina
University of Oklahoma
University of Pennsylvania
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Infertility, Female
Interventions Other: Caloric Restriction
Drug: Orlistat
Other: Moderate physical activity
Enrollment 379
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intensive Lifestyle Mod. Intervention Standard Lifestyle Intervention
Hide Arm/Group Description

The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.

Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.

Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Period Title: Overall Study
Started 188 191
Completed 157 151
Not Completed 31 40
Arm/Group Title Intensive Lifestyle Mod. Intervention Standard Lifestyle Intervention Total
Hide Arm/Group Description

The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.

Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.

Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Total of all reporting groups
Overall Number of Baseline Participants 188 191 379
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 188 participants 191 participants 379 participants
32
(29 to 35)
32
(30 to 35)
32
(29 to 35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 188 participants 191 participants 379 participants
Female
188
 100.0%
191
 100.0%
379
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 188 participants 191 participants 379 participants
Hispanic or Latino
3
   1.6%
9
   4.7%
12
   3.2%
Not Hispanic or Latino
179
  95.2%
177
  92.7%
356
  93.9%
Unknown or Not Reported
6
   3.2%
5
   2.6%
11
   2.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 188 participants 191 participants 379 participants
American Indian or Alaska Native
2
   1.1%
2
   1.0%
4
   1.1%
Asian
4
   2.1%
3
   1.6%
7
   1.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
45
  23.9%
37
  19.4%
82
  21.6%
White
126
  67.0%
140
  73.3%
266
  70.2%
More than one race
6
   3.2%
5
   2.6%
11
   2.9%
Unknown or Not Reported
5
   2.7%
4
   2.1%
9
   2.4%
1.Primary Outcome
Title Rate of Good Birth Outcomes
Hide Description Defined as a live birth of an infant born at ≥ 37 weeks, with a birth weight between 2500 and 4000g and without a major congenital anomaly
Time Frame At time of birth, approximately 17 months into the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Lifestyle Mod. Intervention Standard Lifestyle Intervention
Hide Arm/Group Description:

The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.

Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.

Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Overall Number of Participants Analyzed 188 191
Measure Type: Count of Participants
Unit of Measure: Participants
23
  12.2%
29
  15.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive Lifestyle Mod. Intervention, Standard Lifestyle Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.404
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.48 to 1.34
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Live Birth Rate
Hide Description All the live birth for the study
Time Frame At time of birth, approximately 17 months into the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Lifestyle Mod. Intervention Standard Lifestyle Intervention
Hide Arm/Group Description:

The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.

Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.

Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Overall Number of Participants Analyzed 188 191
Measure Type: Count of Participants
Unit of Measure: Participants
38
  20.2%
42
  22.0%
3.Secondary Outcome
Title Time to Pregnancy in Days
Hide Description Days from randomization to the first known date of conception
Time Frame 0-8 months
Hide Outcome Measure Data
Hide Analysis Population Description
For those who achieved pregnancy
Arm/Group Title Intensive Lifestyle Mod. Intervention Standard Lifestyle Intervention
Hide Arm/Group Description:

The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.

Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.

Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Overall Number of Participants Analyzed 59 52
Median (Inter-Quartile Range)
Unit of Measure: days
160
(102 to 190)
163
(98.5 to 214)
4.Secondary Outcome
Title Pregnancy Loss Rate
Hide Description Pregnancy loss (conception without a live birth) among those who achieved pregnancy
Time Frame After conception, 0-13 months into the study
Hide Outcome Measure Data
Hide Analysis Population Description
For those who achieved pregnancy
Arm/Group Title Intensive Lifestyle Mod. Intervention Standard Lifestyle Intervention
Hide Arm/Group Description:

The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.

Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.

Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Overall Number of Participants Analyzed 63 59
Measure Type: Count of Participants
Unit of Measure: Participants
24
  38.1%
14
  23.7%
5.Secondary Outcome
Title Multiple Pregnancy Rate
Hide Description Determined by number of multiple pregnancies / number of pregnancies
Time Frame After conception, 1-13 months into the study
Hide Outcome Measure Data
Hide Analysis Population Description
For those with clinical pregnancy
Arm/Group Title Intensive Lifestyle Mod. Intervention Standard Lifestyle Intervention
Hide Arm/Group Description:

The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.

Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.

Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Overall Number of Participants Analyzed 48 45
Measure Type: Count of Participants
Unit of Measure: Participants
7
  14.6%
3
   6.7%
6.Secondary Outcome
Title Birth Weight in Grams
Hide Description Birth weight (grams) for infant delivered
Time Frame at time of birth, approximately 17 months into the study
Hide Outcome Measure Data
Hide Analysis Population Description
For the live-born infants
Arm/Group Title Intensive Lifestyle Mod. Intervention Standard Lifestyle Intervention
Hide Arm/Group Description:

The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.

Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.

Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Overall Number of Participants Analyzed 36 42
Median (Inter-Quartile Range)
Unit of Measure: gram
3217.7
(2802.4 to 3642.9)
3189.3
(2636.5 to 3671.3)
7.Secondary Outcome
Title Mode of Delivery-Cesarean Section
Hide Description Babies by Cesarean Section/Number of participants who delivered baby
Time Frame At time of birth, approximately 17 months into the study
Hide Outcome Measure Data
Hide Analysis Population Description
For those who delivered baby(babies)
Arm/Group Title Intensive Lifestyle Mod. Intervention Standard Lifestyle Intervention
Hide Arm/Group Description:

The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.

Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.

Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Overall Number of Participants Analyzed 36 40
Measure Type: Count of Participants
Unit of Measure: Participants
19
  52.8%
23
  57.5%
Time Frame From randomization to 6 weeks following infant delivery (from 0 to up to 18.5 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intensive Lifestyle Mod. Intervention Standard Lifestyle Intervention
Hide Arm/Group Description

The intensive lifestyle modification intervention will consist of caloric restriction (consumption of approximately 1200-1500 kcal/d), use of an over-the-counter weight loss medication (Alli, which is brand name Orlistat, a gastric lipase inhibitor that limits gut fat absorption), and moderate physical activity (goal of reaching 10,000 steps a day). The pretreatment intervention will last 16 weeks and is designed to promote a weight loss of approximately 7% of total body weight.

Caloric Restriction: Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.

Orlistat: Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

Women in the standard lifestyle intervention (standard) will receive publicly available written materials that promote engagement in moderate physical activity with target of 10,000 steps a day. Detailed instruction of physical activity will not be provided.

Moderate physical activity: All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.

All-Cause Mortality
Intensive Lifestyle Mod. Intervention Standard Lifestyle Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/188 (0.00%)   0/191 (0.00%) 
Hide Serious Adverse Events
Intensive Lifestyle Mod. Intervention Standard Lifestyle Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   12/188 (6.38%)   13/191 (6.81%) 
Endocrine disorders     
Hospitalization *  2/188 (1.06%)  0/191 (0.00%) 
Pelvic pain *  1/188 (0.53%)  0/191 (0.00%) 
General disorders     
Appendicitis *  0/188 (0.00%)  1/191 (0.52%) 
Complex cyst resulting in surgical intervention *  0/188 (0.00%)  1/191 (0.52%) 
Hospitalization * [1]  2/63 (3.17%)  1/59 (1.69%) 
Pregnancy, puerperium and perinatal conditions     
Hospitalization during first trimester * [1]  1/63 (1.59%)  0/59 (0.00%) 
Ectopic pregnancy * [1]  1/63 (1.59%)  2/59 (3.39%) 
Pregnancy of Unknown Location * [1]  3/63 (4.76%)  3/59 (5.08%) 
Marginal Placenta Previa * [1]  1/63 (1.59%)  0/59 (0.00%) 
Placenta Previa and Pre-term birth * [1]  0/63 (0.00%)  1/59 (1.69%) 
Hospitalization-infant * [2]  1/38 (2.63%)  2/42 (4.76%) 
Myelomeningocele * [2]  1/38 (2.63%)  0/42 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia *  0/188 (0.00%)  1/191 (0.52%) 
Pulmonary Embolism *  0/188 (0.00%)  1/191 (0.52%) 
*
Indicates events were collected by non-systematic assessment
[1]
For those who achieved pregnancy
[2]
For the live-born infants
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Intensive Lifestyle Mod. Intervention Standard Lifestyle Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   157/188 (83.51%)   157/191 (82.20%) 
Cardiac disorders     
Constipation *  23/188 (12.23%)  7/191 (3.66%) 
Gastrointestinal disorders     
Flatulence *  33/188 (17.55%)  2/191 (1.05%) 
Oily stools/discharge *  43/188 (22.87%)  0/191 (0.00%) 
General disorders     
Diarrhea *  35/188 (18.62%)  9/191 (4.71%) 
Fever *  5/188 (2.66%)  0/191 (0.00%) 
Mood swings *  2/188 (1.06%)  9/191 (4.71%) 
Nausea/vomiting *  41/188 (21.81%)  24/191 (12.57%) 
Abdominal pain *  20/188 (10.64%)  12/191 (6.28%) 
Anxiety/irritability *  11/188 (5.85%)  14/191 (7.33%) 
Back pain *  13/188 (6.91%)  20/191 (10.47%) 
Pregnancy, puerperium and perinatal conditions     
Pre-term labor * [1]  2/63 (3.17%)  6/59 (10.17%) 
Pre-eclampsia/Eclampsia * [1]  4/63 (6.35%)  7/59 (11.86%) 
Gestational Diabetes * [1]  6/63 (9.52%)  10/59 (16.95%) 
Incompetent cervix * [1]  2/63 (3.17%)  0/59 (0.00%) 
Premature rupture of membranes * [1]  2/63 (3.17%)  4/59 (6.78%) 
Placental abnormalities * [1]  5/63 (7.94%)  4/59 (6.78%) 
Post-partum Infection * [1]  0/63 (0.00%)  2/59 (3.39%) 
Post-partum hemorrhage * [1]  0/63 (0.00%)  1/59 (1.69%) 
Other complication * [1]  4/63 (6.35%)  3/59 (5.08%) 
Other post-partum complication(s) * [1]  3/63 (4.76%)  1/59 (1.69%) 
Intrauterine growth restriction * [2]  1/38 (2.63%)  4/42 (9.52%) 
Admission to NICU * [2]  7/38 (18.42%)  12/42 (28.57%) 
Reproductive system and breast disorders     
Dysmenorrhea *  23/188 (12.23%)  25/191 (13.09%) 
*
Indicates events were collected by non-systematic assessment
[1]
For those who achieved pregnancy
[2]
For the live-born infants
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Fangbai Sun
Organization: Yale School of Public Health
Phone: 2037855185
EMail: fangbai.sun@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02432209    
Other Study ID Numbers: FIT-Plese
First Submitted: March 16, 2015
First Posted: May 4, 2015
Results First Submitted: January 15, 2021
Results First Posted: March 15, 2021
Last Update Posted: March 15, 2021