Clinical trial NCT01545934: Preventing Excessive Gestational Weight Gain in Obese Women
Official title: Preventing Excessive Gestational Weight Gain in Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Overweight
Obese
Pregnancy
Weight Gain
Lead sponsor: California Polytechnic State University-San Luis Obispo
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2012-03-07
Enrollment: 264
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Weight Gain Per Week of Observation
timeFrame: 13 weeks gestation, 35 weeks gestation
Secondary outcomes:
measure: Offspring Weight Gain
timeFrame: 1 week, 6 months, 12 months
measure: Kcals/Day
timeFrame: 13 weeks gestation, 34 weeks gestation
measure: Changes in Offspring Dietary Intake
timeFrame: 1 week, 6 months, 12 months
measure: Changes in Maternal Glucose
timeFrame: 13 weeks gestation, 34 weeks gestation
measure: Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group.
timeFrame: 13 weeks, 40 weeks
measure: Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group
timeFrame: 48-56 weeks post delivery
Other outcomes:
Locations:
city: San Luis Obispo
country: United States
facility: California Polytechnic State University
state: California
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Cal Poly
name: Suzanne Phelan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.