Evaluation of Exercise, in Addition to Diet, in Women With Gestational Diabetes

NCT ID: NCT03174340

Last Updated: 2017-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-21
• Study Completion Date: 2013-06-19

Brief Summary

The main objective is to evaluate the effect of therapeutic exercise program on blood glucose regulation in women with gestational diabetes mellitus (GDM) who are assigned to diet-and-exercise, compared to diet only (usual treatment). The primary outcome is the need for insulin treatment in the two groups.

Detailed Description

In women with gestational diabetes, light to moderate daily physical activity may a useful therapeutic approach to improve the control of glycaemia and decrease the need for prescription of insulin. Increased physical activity in pregnant women with gestational diabetes is expected to decrease the mother and child morbidity associated with gestational diabetes, but also to improve the general health status of the mother and the child.

The objectives of this randomized trial are:

• To evaluate the effect of therapeutic exercise program on blood glucose regulation in women with GDM who are assigned to diet-and-exercise protocol.
• To demonstrate the feasibility of the therapeutic exercise treatment and the possibility of using the exercise program as an optional therapeutic approach for women with GDM.

Conditions

Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise + diet

Exercise intervention:

During the first session a standardized exercise prescription will be discussed with the participant. The exercise program will be of a moderate intensity, at less than 140 heart beats/min (which corresponds to 60% of the calculated maximum heart rate (HRmax) or 50% maximum oxygen volume (VO2max) ). A session of 30 to 60 minutes/week will be organised.

• Participants will be instructed to conduct a nonsedentary lifestyle. They will be encouraged to increase their number of steps on a daily basis and perform not more that 45 minutes of continuous exercise per day. Pedometers will be used to measure the compliance and as a positive feedback for motivation.
• The participants will return to the exercise laboratory once per week for Actiheart data downloading, number of steps recording, exercise support and counselling, and to perform the supervised group exercise intervention.

This is in addition to the diet (see below, control group)

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Once per week, participants will be enrolled in supervised group exercise intervention. They will be encouraged in walking 45 minutes per day

Diet only

Participants will receive diet counselling according to their characteristics. The usual recommendation is to have a fractioned normocaloric diet (unless the dietician identify a grossly hypercaloric diet), with low fat and increase in fibers content.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

Once per week, participants will be enrolled in supervised group exercise intervention. They will be encouraged in walking 45 minutes per day

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• gestational diabetes, based on the criteria of Coustan-Carpenter, then on the International Association Diabetes Pregnancy Study Groups (IADPSG )

Exclusion Criteria

• pre-existing diabetes
• twins

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Michel Boulvain

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michel Boulvain

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

References

Boulvain M, Othenin-Girard V, Jornayvaz FR, Kayser B. Impact of an exercise program combined with dietary advice on avoiding insulin prescription in women with gestational diabetes: a randomized controlled trial. Diabetol Metab Syndr. 2024 Sep 30;16(1):238. doi: 10.1186/s13098-024-01470-1.

Reference Type: DERIVED

PMID: 39343942 (View on PubMed)

Other Identifiers

07-080 MATPED 07-021

Identifier Type: -

Identifier Source: org_study_id