Obesity; FamilialNCT03244722

Maternal Metabolic and Molecular Changes Induced by Preconception Weight Loss and Their Effects on Birth Outcomes

A study testing Very-low energy Diet (VLED) in people with Obesity; Familial and Pregnancy Related, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Our hypothesis is that aggressive preconception weight loss in obese women will improve the metabolic health of the mother and the intrauterine environment. An optimized developmental environment will normalize fetal growth and improve clinical fetal and infant outcomes, and theoretically reduce future susceptibility… Read more about this study

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Obesity; Familial, Pregnancy Related
What is being tested?: Very-low energy Diet (VLED)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 147 participants
Where: 1 siteUnited States
Study dates: 10 Apr 2018to 29 Aug 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

BMI > 30 ≤ 45 for obese participants OR
BMI ≤ 25 for healthy body weight participants
No known infertility
No known risk factors for tubal disease

Who cannot join

Significant medical co-morbidities (e.g. heart, kidney, liver, autoimmune disease)
Significant anemia
Cancer other than minor skin cancers
Conditions that would complicate pregnancy
Recent use of anti-obesity drugs or appetite suppressants
Previous bariatric surgery

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Endometriosis AFS (American Fertility Society classification class III or IV)
Progesterone > 10 IU/ml
Current pregnancy
Use of sperm donor

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48106

Other trials in United States

About this study

Read the detailed description

Further, our hypothesis is that the metabolic profiles in the mother and infant cord blood and epigenetic profiles in cord blood leukocytes will be improved in the very-low energy diet (VLED) group compared to standard practice nutrition counseling and support (SOC) group and approach the profiles found in normal weight (LEAN) individuals. We will relate these changes to the changes in the offspring clinical profiles. With these data in hand, we will develop a model to understand the potential molecular markers associated with offspring size and adiposity at birth, risk factors for later onset non-communicable diseases. We will use these insights to define, adopt and implement future interventions that mitigate the downstream risk of adiposity and cardiometabolic diseases.

Conditions: Obesity; Familial, Pregnancy Related
Being tested: Very-low energy Diet (VLED), Standard of care (SOC)
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Very-low energy Diet (VLED)Dietary supplement
Structured, intensive dietary intervention using liquid meal replacements aimed at providing 800 kcal/day with a weight loss goal of 15% from baseline
Standard of care (SOC)Other
Standard consultation with registered dietitian to determine appropriate caloric deficit for a low calorie diet, education and advice to achieve weight loss in obese women. Standard of care for normal weight women

Study groups in NCT03244722
Study group	Role	What they receive
Obese - Very low energy diet (VLED)	Other	Participants will adopt a very-low energy diet Receives: Dietary Supplement: Very-low energy Diet (VLED)
Obese - Standard of care (SOC)	Active comparator	Participants will receive the standard of care for obese dietary education and advice to incorporate a low-calorie food based diet Receives: Other: Standard of care (SOC)
LEAN	No intervention	Healthy weight women followed in parallel. No dietary intervention prior to conceiving.

What is being measured

The primary outcome is the main question the study is designed to answer.

Preconception Weight Loss
Primary pre-specified outcome is BMI change (kg/m2) after dietary intervention. Trained staff will measure height and weight to the nearest .1cm and .1kg using a wall-mounted, precision stadiometer and calibrated digital scale. BMI will be calculated (kg/m2).
Measured: Baseline to conception (up to 68 weeks post enrollment)
Maternal Diagnosis
Gestational diabetes or hypertensive disorders in pregnancy
Measured: Throughout pregnancy (up to 108 weeks post enrollment)
Offspring Body Fat Mass
Percentage body fat (adiposity) in the offspring of women randomized to Very Low Energy Diet (VLED) compared to those randomized to Standard of Care (SOC). Body composition will be assessed by PeaPod (fat mass in grams).
Measured: Delivery (up to 108 weeks post enrollment)

Secondary outcomes (3)

Fetal Growth Will be Assessed by Ultrasound
Abdominal circumference (cm) will be assessed through ultrasound to determine fetal growth.
Measured: 2nd trimester (up to 90 weeks post enrollment) and 3rd trimester (up to 102 weeks post enrollment) of pregnancy
Ponderal Index
Trained staff will measure infant length and weight to the nearest .1cm and .1kg using an infant length board and digital infant scale. Ponderal index will be calculated and used to assess growth from baseline to 12 months post birth.
Ponderal index is weight/length (grams/cubic centimeters).
Measured: Delivery (up to 108 weeks post enrollment) up to 12 month post delivery follow-up (up to 160 weeks post enrollment)
Mode of Delivery
Categorical as caesarean or vaginal delivery
Measured: Delivery (up to 108 weeks post enrollment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 201829 Aug 2025

First posted9 Aug 2017
Study start10 Apr 2018
Primary completion14 Jun 2025
Study completion29 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Obesity; FamilialStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 147 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03244722
Sponsor's protocol ID: HUM00124673
Other IDs: 1R01DK124862
Status last verified: Jul 2026
First submitted: 5 Aug 2017
Last updated: 4 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity; Familial trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Maternal Metabolic and Molecular Changes Induced by Preconception Weight Loss and Their Effects on Birth Outcomes
ClinicalTrials.gov ID: NCT03244722
Acronym / sponsor ID: HUM00124673
Conditions: Obesity; Familial, Pregnancy Related
Study type: Interventional
Recruitment status: Completed
Enrolment: 147 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 10 Apr 2018 (actual)
Primary completion: 14 Jun 2025 (actual)
Study completion: 29 Aug 2025 (actual)
First posted: 9 Aug 2017 (actual)
Results: Posted 4 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Obese - Very low energy diet (VLED)	Other	Dietary Supplement: Very-low energy Diet (VLED)Participants will adopt a very-low energy diet
Obese - Standard of care (SOC)	Active comparator	Other: Standard of care (SOC)Participants will receive the standard of care for obese dietary education and advice to incorporate a low-calorie food based diet
LEAN	No intervention	–Healthy weight women followed in parallel. No dietary intervention prior to conceiving.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

BMI > 30 ≤ 45 for obese participants OR
BMI ≤ 25 for healthy body weight participants
No known infertility
No known risk factors for tubal disease

Key exclusion criteria (10 listed)

Significant medical co-morbidities (e.g. heart, kidney, liver, autoimmune disease)
Significant anemia
Cancer other than minor skin cancers
Conditions that would complicate pregnancy
Recent use of anti-obesity drugs or appetite suppressants

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Very-low energy Diet (VLED)Structured, intensive dietary intervention using liquid meal replacements aimed at providing 800 kcal/day with a weight loss goal of 15% from baseline	Dietary supplement	Obese - Very low energy diet (VLED)
Standard of care (SOC)Standard consultation with registered dietitian to determine appropriate caloric deficit for a low calorie diet, education and advice to achieve weight loss in obese women. Standard of care for normal weight women	Other	Obese - Standard of care (SOC)

Primary outcome

Preconception Weight Loss
Time frame: Baseline to conception (up to 68 weeks post enrollment)
Primary pre-specified outcome is BMI change (kg/m2) after dietary intervention. Trained staff will measure height and weight to the nearest .1cm and .1kg using a wall-mounted, precision stadiometer and calibrated digital scale. BMI will be calculated (kg/m2).
Maternal Diagnosis
Time frame: Throughout pregnancy (up to 108 weeks post enrollment)
Gestational diabetes or hypertensive disorders in pregnancy
Offspring Body Fat Mass
Time frame: Delivery (up to 108 weeks post enrollment)
Percentage body fat (adiposity) in the offspring of women randomized to Very Low Energy Diet (VLED) compared to those randomized to Standard of Care (SOC). Body composition will be assessed by PeaPod (fat mass in grams).

3 secondary outcomes

Fetal Growth Will be Assessed by Ultrasound
Time frame: 2nd trimester (up to 90 weeks post enrollment) and 3rd trimester (up to 102 weeks post enrollment) of pregnancy
Ponderal Index
Time frame: Delivery (up to 108 weeks post enrollment) up to 12 month post delivery follow-up (up to 160 weeks post enrollment)
Mode of Delivery
Time frame: Delivery (up to 108 weeks post enrollment)

Results and safety

Results posted to the registry on 4 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Obese - Very Low Energy Diet (VLED)	49	22
Obese - Standard of Care (SOC)	45	27
LEAN	53	35

Primary outcome: Preconception Weight Loss

Time frame: Baseline to conception (up to 68 weeks post enrollment). Mean (Standard Deviation). Unit: kg/m2

Measure	Obese - Very Low Energy Diet (VLED) n = 22	Obese - Standard of Care (SOC) n = 27	LEAN n = 35
Baseline (preconception) BMI	35.0 (2.9)	35.9 (4.3)	23.2 (1.8)
BMI at conception	31.0 (3.6)	35.0 (4.5)	23.1 (1.9)

Primary outcome: Maternal Diagnosis

Time frame: Throughout pregnancy (up to 108 weeks post enrollment). Count of participants. Unit: Participants

Measure	Obese - Very Low Energy Diet (VLED) n = 22	Obese - Standard of Care (SOC) n = 27	LEAN n = 35
Hypertension	6	11	3
Gestational Diabetes	1	3	3

Primary outcome: Offspring Body Fat Mass

Time frame: Delivery (up to 108 weeks post enrollment). Mean (Standard Deviation). Unit: percent body fat

Measure	Obese - Very Low Energy Diet (VLED) n = 22	Obese - Standard of Care (SOC) n = 27	LEAN n = 35
Value	15.7 (3.5)	11.6 (4.0)	13.2 (6.4)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 3.5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Obese - Very Low Energy Diet (VLED)	2 of 49 (4.1%)	10 of 49 (20.4%)	0 of 49
Obese - Standard of Care (SOC)	0 of 45 (0%)	29 of 45 (64.4%)	0 of 45
LEAN	1 of 53 (1.9%)	31 of 53 (58.5%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Obesity; Familial

Active, not recruiting
Motivational Interviewing Intervention for Families With Overweight and Obesity
Obesity & Overweight
Not yet recruiting
Weight Gain in Pediatric Leukemia Survivors
Leukemia, Pediatric Acute Lymphoblastic Leukemia
Enrolling by invitation
Family Intervention to Prevent Childhood Obesity
Childhood Obesity
Enrolling by invitation
EFFECT OF A ONLINE NUTRITION EDUCATION PROGRAM IN PRESCHOOLER'S FAMILIES ON THEIR ADHERENCE TO THE MEDITERRANEAN DIET
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amy Rothberg, MD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Very-low energy Diet (VLED) in people with Obesity; Familial and Pregnancy Related, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preconception Weight Loss (time frame: Baseline to conception (up to 68 weeks post enrollment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03244722.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.