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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
Must not have
Asthma requiring more than occasional use of a sympathomimetic inhaler, but not chronic inhaled steroids
Gastric surgery to lose weight including banding or bypass procedures
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
No Placebo-Only Group

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.
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.
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 below
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I am between 18 and 40 years old.
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My thyroid, blood cell count, kidney, and liver functions are normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I use an asthma inhaler more than just occasionally, but I don't need daily steroid treatment.
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I have had weight loss surgery, such as banding or bypass.
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I do not have HIV, hepatitis B, or hepatitis C.
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I have inflammatory bowel disease.

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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 6 month post-partum and then during pregnancy at 12 to 16 weeks gestation and 34 to 36 weeks gestation. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neonatal adiposity comparison between intervention and usual care group
Secondary study objectives
Maternal metabolic status

Side effects data

From 2008 Phase 2 trial • 114 Patients • NCT00151411
35%
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~8370

Find a Location

Who is running the clinical trial?

MetroHealth Medical CenterOTHER
117 Previous Clinical Trials
21,393 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,660 Previous Clinical Trials
11,699,923 Total Patients Enrolled
Pennington Biomedical Research CenterOTHER
308 Previous Clinical Trials
179,133 Total Patients Enrolled

Media Library

Lifestyle Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03146156 — N/A
Lifestyle-related Condition Research Study Groups: Lifestyle Intervention, Usual Care
Lifestyle-related Condition Clinical Trial 2023: Lifestyle Intervention Highlights & Side Effects. Trial Name: NCT03146156 — N/A
Lifestyle Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03146156 — N/A
~12 spots leftby Oct 2025
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