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ObesityNCT01545934

Preventing Excessive Gestational Weight Gain in Obese Women

A study testing Lifestyle intervention in people with Obesity, run by California Polytechnic State University-San Luis Obispo at 2 sites 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

The purpose of this study is to study the effects of a multicomponent lifestyle intervention that includes partial meal replacements as a means to prevent excessive gestational weight gain in obese women. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
2 sitesUnited States
Study dates
Nov 2012to Jun 2020
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Over 18 years old
  • < 16 weeks gestation
  • BMI >= 25
  • Willing to consent

Who cannot join

  • Pregnant with Twins
  • Untreated medical or psychological problem
  • Inability to be physically active

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • California Polytechnic State University

    San Luis Obispo, California, 93401

Other trials in United States

About this study

The purpose of this study is to study the effects of a multicomponent lifestyle intervention that includes partial meal replacements as a means to prevent excessive gestational weight gain in obese women. The primary hypothesis is that the intervention will reduce the rate of gestational weight gain compared with standard care.

Conditions
Obesity
Being tested
Lifestyle intervention
Keywords
Overweight, Obese, Pregnancy, Weight Gain
Medical subject headings
Obesity, Overweight, Weight Gain

What participants receive

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

  • Lifestyle interventionBehavioural

    The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.

Study groups in NCT01545934
Study groupRoleWhat they receive
Standard CareNo interventionNot described
Lifestyle interventionExperimentalNot described
Receives: Behavioral: Lifestyle intervention

What is being measured

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

  1. Weight Gain Per Week of Observation

    Rate of gestational weight gain will be computed as difference between weights measured at study entry and gestational week 35; this difference will be divided by the number of weeks of observation during pregnancy (i.e., weeks between study entry and final pregnancy assessment). If gestational week 35 is unavailable, most proximal clinic visit weight will be used.

    Measured: 13 weeks gestation, 35 weeks gestation

Secondary outcomes (6)

  1. Offspring Weight Gain

    Offspring weight for age z scores from birth (1 week), to 6 months, and 12 months of age.

    Measured: 1 week, 6 months, 12 months

  2. Kcals/Day

    Changes in maternal calorie intake (Kcal/day)

    Measured: 13 weeks gestation, 34 weeks gestation

  3. Changes in Offspring Dietary Intake

    Changes in offspring intake of breast milk (#feeds per day) and/or formula (#feeds per day).

    Measured: 1 week, 6 months, 12 months

  4. Changes in Maternal Glucose

    Fasting glucose

    Measured: 13 weeks gestation, 34 weeks gestation

  5. Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group.

    Self-reported pre-pregnancy weight will be subtracted from weight measured at last clinic visit prior to delivery. Women will be categorized as exceeding 2009 IOM guidelines if the difference is > 11.5 kg gain for women with prepregnancy overweight or >9 kg for women with prepregnancy obesity.

    Measured: 13 weeks, 40 weeks

  6. Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group

    Weight measured at 48-56 weeks postpartum and subtracted from self-reported prepregnancy weight and then categorized as at or below vs. above self-reported prepregnancy weight.

    Measured: 48-56 weeks post delivery

Timeline

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

  1. First posted7 Mar 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionMay 2016
  4. Study completionJun 2020

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
264 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01545934
Sponsor's protocol ID
U01 HL114377A
Other IDs
U01HL114377
Status last verified
Jul 2021
First submitted
28 Feb 2012
Last updated
2 Aug 2021
Data monitoring committee
Yes

Publications

  • Cabre HE, Drews KL, Pomeroy J, Keadle SK, Arteaga SS, Franks PW, Haire-Joshu D, Knowler WC, Pi-Sunyer X, Van Horn L, Wing RR, Cahill AG, Clifton RG, Couch KA, Gallager D, Josefson JL, Joshipura K, Klein S, Martin CK, Peaceman AM, Phelan S, Thom EA, Redman LM; LIFE-Moms Research Group. LIFE-Moms: effects of multicomponent lifestyle randomized control trial on physical activity during pregnancy in women with overweight and obesity. Int J Behav Nutr Phys Act. 2025 Sep 30;22(1):119. doi: 10.1186/s12966-025-01805-9.

    PubMed 41029405

  • Flanagan EW, Drews KL, Cade WT, Franks PW, Gallagher D, Phelan S, Van Horn L, Redman LM. Metabolic Health and Heterogenous Outcomes of Prenatal Interventions: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2528264. doi: 10.1001/jamanetworkopen.2025.28264.

    PubMed 40839263

  • Redman LM, Drews KL, Klein S, Horn LV, Wing RR, Pi-Sunyer X, Evans M, Joshipura K, Arteaga SS, Cahill AG, Clifton RG, Couch KA, Franks PW, Gallagher D, Haire-Joshu D, Martin CK, Peaceman AM, Phelan S, Thom EA, Yanovski SZ, Knowler WC; LIFE-Moms Research Group. Attenuated early pregnancy weight gain by prenatal lifestyle interventions does not prevent gestational diabetes in the LIFE-Moms consortium. Diabetes Res Clin Pract. 2021 Jan;171:108549. doi: 10.1016/j.diabres.2020.108549. Epub 2020 Nov 22.

    PubMed 33238176

  • Phelan S, Wing RR, Brannen A, McHugh A, Hagobian T, Schaffner A, Jelalian E, Hart CN, Scholl TO, Munoz-Christian K, Yin E, Phipps MG, Keadle S, Abrams B. Does Partial Meal Replacement During Pregnancy Reduce 12-Month Postpartum Weight Retention? Obesity (Silver Spring). 2019 Feb;27(2):226-236. doi: 10.1002/oby.22361. Epub 2018 Nov 13.

    PubMed 30421864

  • Peaceman AM, Clifton RG, Phelan S, Gallagher D, Evans M, Redman LM, Knowler WC, Joshipura K, Haire-Joshu D, Yanovski SZ, Couch KA, Drews KL, Franks PW, Klein S, Martin CK, Pi-Sunyer X, Thom EA, Van Horn L, Wing RR, Cahill AG; LIFE-Moms Research Group. Lifestyle Interventions Limit Gestational Weight Gain in Women with Overweight or Obesity: LIFE-Moms Prospective Meta-Analysis. Obesity (Silver Spring). 2018 Sep;26(9):1396-1404. doi: 10.1002/oby.22250. Epub 2018 Sep 6.

    PubMed 30230252

  • Phelan S, Wing RR, Brannen A, McHugh A, Hagobian TA, Schaffner A, Jelalian E, Hart CN, Scholl TO, Munoz-Christian K, Yin E, Phipps MG, Keadle S, Abrams B. Randomized controlled clinical trial of behavioral lifestyle intervention with partial meal replacement to reduce excessive gestational weight gain. Am J Clin Nutr. 2018 Feb 1;107(2):183-194. doi: 10.1093/ajcn/nqx043.

    PubMed 29529157

  • Clifton RG, Evans M, Cahill AG, Franks PW, Gallagher D, Phelan S, Pomeroy J, Redman LM, Van Horn L; LIFE-Moms Research Group. Design of lifestyle intervention trials to prevent excessive gestational weight gain in women with overweight or obesity. Obesity (Silver Spring). 2016 Feb;24(2):305-13. doi: 10.1002/oby.21330. Epub 2015 Dec 26.

    PubMed 26708836

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle intervention in people with Obesity, run by California Polytechnic State University-San Luis Obispo at 2 sites 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 3 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 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 28 Jan 2021). 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?

Weight Gain Per Week of Observation (time frame: 13 weeks gestation, 35 weeks gestation). 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 NCT01545934, which also lists 7 linked publications.

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 2 Aug 2021.

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