Weight Loss Clinical Trial
Official title:
Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women
Verified date | July 2022 |
Source | University of Tennessee |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to enroll approximately 450 subjects to see if a behavioral weight management program is successful in helping TRICARE beneficiaries who are pregnant or post-partum to manage their weight during and after their pregnancy.
Status | Completed |
Enrollment | 430 |
Est. completion date | May 26, 2022 |
Est. primary completion date | November 10, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participants will be active duty military, dependents or retired with TRICARE benefits - Participants must be less than 12 weeks gestation upon recruitment (based on the date of their last menstrual period and then confirmed by their physician at their first prenatal visit, which typically occurs at 6-8 weeks gestation at WHASC and SAMMC) - Participants also must be within the normal, overweight, or obese BMI ranges - Are generally in good health - Currently not smoking more than 5 cigarettes per day at the time of conception Exclusion Criteria: - Expecting multiple babies (e.g. twins) - Diabetic - Not interested in participating in a program for 21 months |
Country | Name | City | State |
---|---|---|---|
United States | San Antonio Military Medical Center Obstetrics Clinic (SAMMC) | San Antonio | Texas |
United States | Wilford Hall Ambulatory Surgical Center | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Tennessee | 59th Medical Wing, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), San Antonio Military Medical Center, University of Tennessee Health Science Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in the Mother's Body Weight Pre and Post Pregnancy | At all measurement visits, weight will be recorded in kilograms. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes. While Investigators obtain the mother's weight at baseline, there will also be a self reported pregravid weight (before the last menstrual period). | Baseline to 6 months postpartum | |
Secondary | Maternal and Fetal Conditions During Pregnancy | Pregnancy-related medical outcomes will be obtained from the participant's medical record and will include: maternal (e.g., gestational diabetes, preeclampsia) and fetal conditions. | Baseline (13 weeks gestational to delivery) | |
Secondary | Birth Weight of Infant | Birth weight of the infant will be recorded in grams. | Delivery | |
Secondary | Length of Infant | Birth height of the infant will be recorded in centimeters. | Delivery | |
Secondary | Waist Circumference on Fitness Test Scores | Waist circumference will be recorded in centimeters. | Baseline and 12 months postpartum | |
Secondary | Number of Push Ups on Fitness Test Scores | Number of push ups completed. | Baseline and 12 months postpartum | |
Secondary | Number of Sit Ups on Fitness Test Scores | Number of sit ups completed. | Baseline and 12 months postpartum | |
Secondary | 1.5 Mile Run on Fitness Test Scores | The amount of time it took to complete 1.5 miles. | Baseline and 12 months postpartum | |
Secondary | Moms Fit 2 Fight Program Evaluation Form | Program satisfaction will be assessed using the Investigators program evaluation form to offer insight into program acceptability as well as barriers and facilitators to participation in each intervention arm. Participants will be given 10 statements to rate their experience using a 5 point scale. | 12 months postpartum |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Active, not recruiting |
NCT04420936 -
Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program
|
N/A | |
Terminated |
NCT03316105 -
Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers
|
N/A | |
Completed |
NCT03700736 -
The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups
|
N/A | |
Active, not recruiting |
NCT04353726 -
Knowledge-based Dietary Weight Management.
|
N/A | |
Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Completed |
NCT03377244 -
Healthy Body Healthy Souls in the Marshallese Population
|
N/A | |
Completed |
NCT02877004 -
LLLT for Reducing Waste Circumference and Weight
|
N/A | |
Active, not recruiting |
NCT04327141 -
Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women
|
N/A | |
Completed |
NCT03929198 -
Translation of Pritikin Program to the Community
|
N/A | |
Recruiting |
NCT05249465 -
Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention
|
N/A | |
Recruiting |
NCT05942326 -
Sleep Goal-focused Online Access to Lifestyle Support
|
N/A | |
Completed |
NCT00535600 -
Effects of Bariatric Surgery on Insulin
|
||
Not yet recruiting |
NCT03601273 -
Bariatric Embolization Trial for the Obese Nonsurgical
|
Phase 1 | |
Active, not recruiting |
NCT04357119 -
Common Limb Length in One-anastomosis Gastric Bypass
|
N/A | |
Completed |
NCT02948517 -
Time Restricted Feeding for Weight Loss and Cardio-protection
|
N/A | |
Completed |
NCT03210207 -
Gastric Plication in Mexican Patients
|
N/A | |
Completed |
NCT02945410 -
Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity
|
N/A | |
Completed |
NCT03139760 -
POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability
|
N/A | |
Recruiting |
NCT02559479 -
A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes
|
N/A |