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Lifestyle Intervention for Obesity Before Pregnancy
N/A
Waitlist Available
Research Sponsored by Tufts Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 to 40 years of age at the time of enrollment into the study
Normal thyroid function (determined by TSH concentration in blood), normal cell blood count and normal kidney and liver functions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 6 month post-partum and then during pregnancy at 12 to 16 weeks gestation and 34 to 36 weeks gestation.
Awards & highlights
Study Summary
This trial will help researchers understand if lifestyle intervention before pregnancy can improve maternal and neonatal metabolism and adiposity.
Who is the study for?
The LIPP trial is for women aged 18-40 who plan to get pregnant in the next 24 months, have had a full-term pregnancy before, and are planning to deliver at Tufts Medical Center. They should be using contraception, have normal glucose tolerance or managed gestational diabetes without postpartum diabetes, no severe diseases that affect exercise ability, normal blood pressure and thyroid function, and acceptable blood lipid levels.Check my eligibility
What is being tested?
This study tests whether starting a lifestyle intervention before getting pregnant can improve mothers' metabolism and reduce fat in both the mother and baby. The goal is to see if this approach can break the cycle of obesity by improving how the body uses fats during pregnancy.See study design
What are the potential side effects?
Since this trial involves lifestyle interventions like diet changes and exercise rather than medication, side effects may include typical responses to new physical activities such as muscle soreness or fatigue. Diet changes might cause digestive adjustments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 40 years old.
Select...
My thyroid, blood cell count, kidney, and liver functions are normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 6 month post-partum and then during pregnancy at 12 to 16 weeks gestation and 34 to 36 weeks gestation.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 6 month post-partum and then during pregnancy at 12 to 16 weeks gestation and 34 to 36 weeks gestation.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neonatal adiposity comparison between intervention and usual care group
Secondary outcome measures
Maternal metabolic status
Side effects data
From 2008 Phase 2 trial • 114 Patients • NCT0015141135%
Diarrhea
22%
headache/migraine
22%
common cold/respiratory tract infection
16%
nausea and/or vomiting
15%
flu
13%
dysmenorrhea/cramps
11%
stomach/abdominal pain or discomfort
9%
musculoskeletal
5%
vaginal infection
5%
dizziness
5%
hair loss
5%
dental issues
4%
fatigue
4%
flatulence
2%
bladder infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Metformin
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Lifestyle InterventionExperimental Treatment1 Intervention
Lifestyle coaches will provide personalized instruction on physical activity, dietary data, and behavioral strategies.
Group II: Usual CareActive Control1 Intervention
The usual care/control groups will be followed by their primary Obstetrical provider. All overweight/obese women will be offered nutrition counseling early in pregnancy by a registered dietician to support GWG within the IOM guidelines.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifestyle Intervention
2001
Completed Phase 2
~8880
Find a Location
Who is running the clinical trial?
MetroHealth Medical CenterOTHER
114 Previous Clinical Trials
21,189 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,609 Previous Clinical Trials
11,470,127 Total Patients Enrolled
Pennington Biomedical Research CenterOTHER
304 Previous Clinical Trials
181,236 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need medical help to get pregnant.I don't have heart disease or any condition that would stop me from exercising.I use an asthma inhaler more than just occasionally, but I don't need daily steroid treatment.I have had weight loss surgery, such as banding or bypass.You have a mental health condition that may make it hard for you to take part in the lifestyle intervention program.You have carried a baby to full term (more than 37 weeks).You have normal blood sugar levels or gestational diabetes during pregnancy, but not diabetes after giving birth as determined by a specific test.I am between 18 and 40 years old.I do not have HIV, hepatitis B, or hepatitis C.You are pregnant with more than one baby.My thyroid, blood cell count, kidney, and liver functions are normal.You use tobacco, drink more than 2 alcoholic drinks per day, or use illegal drugs.You have an eating disorder like bulimia.Your blood fat levels should be within a certain range when you haven't eaten for a while.If a person becomes pregnant before a certain time in the study, they will not be able to continue in the study.My blood pressure is normal, or was mildly high during pregnancy but is now normal.You have diabetes before or after giving birth.You have high blood pressure that needs to be treated with medication after giving birth.I have given birth vaginally or by cesarean section.I have inflammatory bowel disease.
Research Study Groups:
This trial has the following groups:- Group 1: Lifestyle Intervention
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current sample size of this research endeavor?
"Affirmative. According to clinicaltrials.gov, this research protocol is actively enrolling participants as of January 7th 2022; the trial was first posted on March 21st 2017 and requires 200 patients from 4 distinct sites."
Answered by AI
Who meets the necessary criteria to qualify for enrollment in this medical research?
"This clinical trial aims to enrol 200 people suffering from fetal macrosomia, aged between 18 and 40. A number of criteria must be met for successful acceptance: Normal thyroid activity (TSH concentration in blood), regular cell count with triglyceride levels not exceeding 400 mg/dl (fasting) and LDL lower than 180 mg/dL, intention to conceive another child within the next two years, arrangement for delivery at Tufts Medical Center during their subsequent pregnancy, a prior full-term singleton gestation (> 37 weeks gestational age), no earlier than 18 or later than 40 years old upon enrollment into the study; vaginal birth or ces"
Answered by AI
Is geriatric eligibility an option for this research protocol?
"This trial requires that enrollees are between 18 and 40 years of age. 203 studies focus on those under the legal age, while 598 are intended for individuals beyond retirement age."
Answered by AI
Are recruitment efforts still underway for this clinical experiment?
"This research, published on clinicaltrials.gov in March 2017 and recently updated in January 2022, is actively recruiting participants."
Answered by AI
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