Clinical trial NCT02763150: Pre-pregnancy Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes in Overweight and Obese Women
Official title: Gestational Diabetes Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Keywords: Gestational Diabetes Prevention
Lead sponsor: California Polytechnic State University-San Luis Obispo
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2016-05-05
Enrollment: 199
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 overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women with overweight or obesity.


Eligibility criteria: Inclusion Criteria:

* Prior diagnosis of gestational diabetes.
* BMI \> 25 kg/m2
* Planning to have a baby in the next 1-3 years
* English or Spanish speaking

Exclusion Criteria:

* Age less than 18 years
* Women with Type 2 or Type 1 diabetes
* Current pregnancy
* Relocating in the next 2 years
* Medications that affect weight/diabetes
* Serious current physical disease
* History of eating disorders
* History of bariatric surgery
* Current problems with drug abuse
* Current treatment of a serious psychological disorder

Primary outcomes:
measure: Incidence of Gestational Diabetes Mellitus
timeFrame: 26 weeks gestation
Secondary outcomes:
measure: Changes in maternal levels of fasting glucose
timeFrame: study entry, 16 weeks, 26 weeks gestation
measure: Changes in maternal levels of fasting insulin
timeFrame: study entry, 16 weeks, 26 weeks gestation
measure: Changes in maternal levels of systolic and diastolic blood pressure
timeFrame: study entry, 16 weeks, 26 weeks gestation
measure: Changes in maternal levels of C-reactive protein
timeFrame: study entry, 16 weeks, 26 weeks gestation
measure: Incidence of preeclampsia
timeFrame: Delivery
measure: Incidence of cesarean delivery
timeFrame: Delivery
measure: Weight changes
timeFrame: study entry, 16 weeks, 26 weeks gestation
measure: Daily caloric intake
timeFrame: study entry, 16 weeks, 26 weeks gestation
measure: Minutes per week of moderate physical activity
timeFrame: study entry, 16 weeks, 26 weeks gestation
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: California Polytechnic State University-San Luis Obispo
name: Suzanne Phelan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phelan S, Jelalian E, Coustan D, Caughey AB, Castorino K, Hagobian T, Munoz-Christian K, Schaffner A, Shields L, Heaney C, McHugh A, Wing RR. Protocol for a randomized controlled trial of pre-pregnancy lifestyle intervention to reduce recurrence of gestational diabetes: Gestational Diabetes Prevention/Prevencion de la Diabetes Gestacional. Trials. 2021 Apr 7;22(1):256. doi: 10.1186/s13063-021-05204-w.