NCT01545934

Brief 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. The primary hypothesis is that the intervention will reduce the rate of gestational weight gain compared with standard care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
8 months until next milestone

Results Posted

Study results publicly available

January 28, 2021

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

3.5 years

First QC Date

February 28, 2012

Results QC Date

August 27, 2020

Last Update Submit

July 29, 2021

Conditions

Obesity

Keywords

OverweightObesePregnancyWeight Gain

Outcome Measures

Primary Outcomes (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.

    13 weeks gestation, 35 weeks gestation

Secondary Outcomes (6)

  • Offspring Weight Gain

    1 week, 6 months, 12 months

  • Kcals/Day

    13 weeks gestation, 34 weeks gestation

  • Changes in Offspring Dietary Intake

    1 week, 6 months, 12 months

  • Changes in Maternal Glucose

    13 weeks gestation, 34 weeks gestation

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

    13 weeks, 40 weeks

  • +1 more secondary outcomes

Study Arms (2)

Standard Care

NO INTERVENTION

Lifestyle intervention

EXPERIMENTAL
Behavioral: Lifestyle intervention

Interventions

Lifestyle interventionBEHAVIORAL

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.

Lifestyle intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

California Polytechnic State University

San Luis Obispo, California, 93401, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (7)

  • 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.

    PMID: 41029405DERIVED

  • 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.

    PMID: 40839263DERIVED

  • 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.

    PMID: 33238176DERIVED

  • 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.

    PMID: 30421864DERIVED

  • 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.

    PMID: 30230252DERIVED

  • 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.

    PMID: 29529157DERIVED

  • 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.

    PMID: 26708836DERIVED

MeSH Terms

Conditions

ObesityOverweightWeight Gain

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Results Point of Contact

Title
Suzanne Phelan
Organization
Cal Poly
sphelan@calpoly.edu
805-756-2087

Study Officials

  • Suzanne Phelan, PhD

    Cal Poly

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 28, 2012

First Posted

March 7, 2012

Study Start

November 1, 2012

Primary Completion

May 1, 2016

Study Completion

June 1, 2020

Last Updated

August 2, 2021

Results First Posted

January 28, 2021

Record last verified: 2021-07

Locations

US(2)