Obesity; Familial / Very-low energy Diet (VLED) / Pregnancy Related · Interventional Study

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

ClinicalTrials.gov · September 4, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed interventional trial comparing very-low energy diet to standard care in obese women planning pregnancy, with primary outcomes spanning preconception weight loss, maternal metabolic and diagnostic measures during pregnancy, and offspring body fat at delivery. Results are not yet posted in this registry record, precluding assessment of efficacy or harm.

What was studied

Interventional, Randomized, Parallel, Open label, Basic Science purpose. Obesity; Familial, Pregnancy Related; Female; age from 18 Years; to 40 Years; accepts healthy volunteers. Intervention: Obese - Very low energy diet (VLED). Compared with: Obese - Standard of care (SOC) — Active Comparator; LEAN — No Intervention. n = 147. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

A completed interventional trial with enrolled participants studying preconception weight loss and birth outcomes, but no results are posted in this registry record; the study design and primary endpoints are specified but outcomes remain unreported.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Preconception Weight Loss (assessed at Baseline to conception (up to 68 weeks post enrollment)); Maternal Diagnosis (assessed at Throughout pregnancy (up to 108 weeks post enrollment)); Offspring Body Fat Mass (assessed at Delivery (up to 108 weeks post enrollment))

DesignInterventional, Randomized, Parallel, Open label, Basic Science purpose

PopulationObesity; Familial, Pregnancy Related; Female; age from 18 Years; to 40 Years; accepts healthy volunteers

Sample size147

InterventionObese - Very low energy diet (VLED)

ComparatorObese - Standard of care (SOC) — Active Comparator; LEAN — No Intervention

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Sample size (actual enrollment)147

Primary outcome measure 1Preconception Weight Loss, Baseline to conception (up to 68 weeks post enrollment)

Primary outcome measure 2Maternal Diagnosis, Throughout pregnancy (up to 108 weeks post enrollment)

Primary outcome measure 3Offspring Body Fat Mass, Delivery (up to 108 weeks post enrollment)

Caveats

Results are not reported in this registry record; outcomes remain unknown.
Study phase is listed as 'NA'; trial design details (blinding, allocation method) not specified.
No power calculation or sample size justification provided.
Follow-up duration and completion rates not reported.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Interventional study with two arms (VLED vs SOC); phase not specified; completed enrollment.

Directness

strong

Primary endpoints include maternal metabolic changes, pregnancy outcomes, and offspring body composition.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

No methodological details on blinding, allocation concealment, or follow-up completeness reported.

Sample adequacy

moderate

147 actual participants enrolled; power calculation not stated in registry record.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT03244722). This is a study registration, not published results. Lead sponsor: University of Michigan. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 147 participants (ACTUAL). Conditions: Obesity; Familial, Pregnancy Related. Interventions: DIETARY_SUPPLEMENT: Very-low energy Diet (VLED); OTHER: Standard of care (SOC). Primary outcome measures: Preconception Weight Loss , Baseline to conception (up to 68 weeks post enrollment); Maternal Diagnosis , Throughout pregnancy (up to 108 weeks post enrollment); Offspring Body Fat Mass , Delivery (up to 108 weeks post enrollment). Brief 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 to obesity and cardiometabolic disease.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

University of MichiganObesity; FamilialNCT03244722Very-low energy Diet (VLED)Pregnancy Related