Lifestyle Intervention Program for Women With Gestational Diabetes or Gestational Impaired Glucose Tolerance

NCT01489163 | Completed

• 1 other identifier: CN-03AFerr-02-H
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to implement and evaluate a lifestyle program designed to help women who have high glucose levels during pregnancy make healthful diet and physical activity changes to lose weight. Eligible women will be randomly assigned to life-style intervention or usual medical care.

Conditions

Gestational Diabetes

Keywords

Gestational Diabetes; Weight Loss; Physical Activity; Pregnancy; Postpartum; Intervention

Outcome Measures

Primary Outcomes (1)

• postpartum body weight

  through 24 months postpartum

Secondary Outcomes (4)

• the proportion of women who reach body weight goals

  through 24 months postpartum

• percent of calories from fat

  through 24 months postpartum

• time spent in physical activity (PA) by intensity

  through 24 months postpartum

• postpartum glycemia

  through 24 months postpartum

Study Arms (2)

Lifestyle Counseling

EXPERIMENTAL

Behavioral: Lifestyle Counseling

Control

NO INTERVENTION

Interventions

Lifestyle Counseling BEHAVIORAL

The Phase I intervention will be delivered through 1 individual in-person session and 3 individual telephone counseling contacts. The Phase II intervention begins at 6-week postpartum and will be delivered through 3 individual in-person sessions and 13 telephone counseling contacts over a period of 6 months. The maintenance phase (Phase III) will begin at 8 months postpartum.

Lifestyle Counseling

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women receiving prenatal care at Kaiser Permanente Santa Clara, Santa Teresa, Hayward, and Oakland
• Pregnancy complicated by high glucose levels starting November 2011

You may not qualify if:

• Recognized DM prior to pregnancy
• Uncontrolled hypertension during pregnancy
• Severe active thyroid disease during pregnancy
• Severe diseases of the cardio-pulmonary system
• Diagnosis of a severe psychiatric disorder
• Diagnosis of cancer
• Conditions that lead to diet changes
• Addiction to alcohol or illegal drugs
• Current corticosteroid medicine use

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Division of Research Northern California

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Assiamira Ferrara, MD, PhD

  Kaiser Permanente Division of Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 9, 2011
• Study Start: December 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2017
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

US (1)