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Preventing Excessive Gestational Weight Gain in Obese Women

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
California Polytechnic State University-San Luis Obispo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Overweight, Obese, Pregnancy, Weight Gain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • California Polytechnic State University
  • Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

Lifestyle intervention

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Offspring Weight Gain
Offspring weight for age z scores from birth (1 week), to 6 months, and 12 months of age.
Kcals/Day
Changes in maternal calorie intake (Kcal/day)
Changes in Offspring Dietary Intake
Changes in offspring intake of breast milk (#feeds per day) and/or formula (#feeds per day).
Changes in Maternal Glucose
Fasting glucose
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.
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.

Full Information

First Posted
February 28, 2012
Last Updated
July 29, 2021
Sponsor
California Polytechnic State University-San Luis Obispo
Collaborators
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT01545934
Brief Title
Preventing Excessive Gestational Weight Gain in Obese Women
Official Title
Preventing Excessive Gestational Weight Gain in Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Polytechnic State University-San Luis Obispo
Collaborators
Brown University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Overweight, Obese, Pregnancy, Weight Gain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Title
Lifestyle intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight Gain Per Week of Observation
Description
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.
Time Frame
13 weeks gestation, 35 weeks gestation
Secondary Outcome Measure Information:
Title
Offspring Weight Gain
Description
Offspring weight for age z scores from birth (1 week), to 6 months, and 12 months of age.
Time Frame
1 week, 6 months, 12 months
Title
Kcals/Day
Description
Changes in maternal calorie intake (Kcal/day)
Time Frame
13 weeks gestation, 34 weeks gestation
Title
Changes in Offspring Dietary Intake
Description
Changes in offspring intake of breast milk (#feeds per day) and/or formula (#feeds per day).
Time Frame
1 week, 6 months, 12 months
Title
Changes in Maternal Glucose
Description
Fasting glucose
Time Frame
13 weeks gestation, 34 weeks gestation
Title
Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group.
Description
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.
Time Frame
13 weeks, 40 weeks
Title
Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group
Description
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.
Time Frame
48-56 weeks post delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Over 18 years old < 16 weeks gestation BMI >= 25 Willing to consent Exclusion Criteria: Pregnant with Twins Untreated medical or psychological problem Inability to be physically active
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Phelan, PhD
Organizational Affiliation
Cal Poly
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Polytechnic State University
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33238176
Citation
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.
Results Reference
derived
PubMed Identifier
30421864
Citation
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.
Results Reference
derived
PubMed Identifier
30230252
Citation
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.
Results Reference
derived
PubMed Identifier
29529157
Citation
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.
Results Reference
derived
PubMed Identifier
26708836
Citation
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.
Results Reference
derived

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Preventing Excessive Gestational Weight Gain in Obese Women

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