Diet and Exercise for Gestational Diabetes
(IDEA Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Manitoba
Disqualifiers: Hypertension, Diabetes, Multiple gestations, others
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?The general goal of the present study is to assess the impact of a community-based exercise and dietary intervention in pregnant women living in urban areas during and after their pregnancy on the reduction of the risks of both diabetes and obesity in mothers and their offspring.
We hypothesize that a community-based lifestyle intervention program during and after gestation may improve pregnancy outcomes in terms of reducing the risk of developing obesity or type 2 DM in mothers and their children.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the treatment Exercise and dietary education, Lifestyle Intervention, Dietary Counseling, Physical Activity Intervention for gestational diabetes?
Research shows that combining diet with moderate exercise can significantly improve outcomes for pregnant women with gestational diabetes and their babies. Studies indicate that these non-medical strategies help manage blood sugar levels and reduce complications.
12345Is diet and exercise safe for managing gestational diabetes?
Research shows that diet and exercise interventions for gestational diabetes are generally safe for both mothers and babies, with no significant differences in delivery type, infant birth weight, or other major health outcomes.
23467How does the treatment of exercise and dietary education differ from other treatments for gestational diabetes?
This treatment focuses on lifestyle changes, combining exercise and dietary education to manage gestational diabetes, which is different from medication-based approaches. It emphasizes personalized nutrition education and physical activity, aiming to improve blood sugar control and reduce weight gain during pregnancy.
348910Eligibility Criteria
This trial is for pregnant women living in urban areas, less than 20 weeks into their pregnancy, who are interested in participating. It's not for those with multiple pregnancies, pre-existing diabetes (except past gestational diabetes), or medical reasons that make exercise unsafe during pregnancy.Inclusion Criteria
I am pregnant and less than 20 weeks along.
I am interested and willing to participate in the study.
Exclusion Criteria
You are pregnant with more than one baby.
You have certain medical conditions during pregnancy that make it unsafe for you to exercise, according to specific guidelines.
You have diabetes that existed before the start of this study, except if you had gestational diabetes during a previous pregnancy.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants receive a community-based exercise and dietary intervention during pregnancy
During pregnancy
Postpartum Intervention
Continuation of lifestyle intervention after pregnancy to assess impact on obesity and diabetes risk
After pregnancy
Follow-up
Participants are monitored for safety and effectiveness after the intervention
6 months
Participant Groups
The study tests a community-based program focusing on exercise and diet education to see if it can reduce the risk of obesity and type 2 diabetes in mothers and their children after birth.
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Lifestyle intervention
Group II: ControlActive Control1 Intervention
No intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of ManitobaWinnipeg, Canada
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Who Is Running the Clinical Trial?
University of ManitobaLead Sponsor
The Lawson FoundationCollaborator
Public Health Agency of Canada (PHAC)Collaborator
References
American Diabetes Association's Fourth International Workshop-Conference on Gestational Diabetes Mellitus: summary and discussion. Therapeutic interventions. [2018]This review summarizes Session IV: Therapeutic Interventions of the Fourth International Gestational Diabetes Workshop and suggests intervention protocols based on the presentations at this meeting and the literature. The opinions of the six presenters and their interpretation of the review of the literature in their specific areas, the synthesis of the 30 abstracts presented at this symposium on therapeutic interventions, and my interpretations of the literature to date on these strategies are discussed. Also, the suggested intervention protocols are outlined as to medical nutritional therapy, weight gain, insulin prescriptions, and the utility of an exercise program for gestational diabetes mellitus. The goals of an intervention protocol for the gestational diabetic women are to achieve and maintain normoglycemia and thus to minimize the risk of maternal or fetal morbidity.
TIMER: A Clinical Study of Energy Restriction in Women with Gestational Diabetes Mellitus. [2021]Medical nutrition therapy is an integral part of gestational diabetes mellitus (GDM) management; however, the prescription of optimal energy intake is often a difficult task due to the limited available evidence. The present pilot, feasibility, parallel, open-label and non-randomized study aimed to evaluate the effect of a very low energy diet (VLED, 1600 kcal/day), or a low energy diet (LED, 1800 kcal/day), with or without personalized exercise sessions, among women with GDM in singleton pregnancies. A total of 43 women were allocated to one of four interventions at GDM diagnosis: (1) VLED (n = 15), (2) VLED + exercise (n = 4), (3) LED (n = 16) or (4) LED + exercise (n = 8). Primary outcomes were gestational weight gain (GWG), infant birth weight, complications at delivery and a composite outcomes score. Secondary outcomes included type of delivery, prematurity, small- for-gestational-age (SGA) or large-for-gestational-age (LGA) infants, macrosomia, Apgar score, insulin use, depression, respiratory quotient (RQ), resting metabolic rate (RMR) and middle-upper arm circumference (MUAC). GWG differed between intervention groups (LED median: 12.0 kg; VLED: 5.9 kg). No differences were noted in the type of delivery, infant birth weight, composite score, prevalence of prematurity, depression, RQ, Apgar score, MUAC, or insulin use among the four groups. Regarding components of the composite score, most infants (88.4%) were appropriate-for-gestational age (AGA) and born at a gestational age of 37-42 weeks (95.3%). With respect to the mothers, 9.3% experienced complications at delivery, with the majority being allocated at the VLED + exercise arm (p < 0.03). The composite score was low (range 0-2.5) for all mother-infant pairs, indicating a "risk-free" pregnancy outcome. The results indicate that adherence to a LED or VLED induces similar maternal, infant and obstetrics outcomes.
Impact of a combined diet and exercise intervention on gestational diabetes. [2018]Review of: Shepherd E et al. Combined diet and exercise interventions for preventing gestational diabetes mellitus. Cochrane Database of Syst Revs 2017; 11: 10.1002/14651858.CD010443.pub3 [Last assessed as up-to-date 27 November 2016].
Simple lifestyle recommendations and the outcomes of gestational diabetes. A 2 × 2 factorial randomized trial. [2022]The benefits of exercise and behavioural recommendations in gestational diabetes mellitus (GDM) are controversial. In a randomized trial with a 2 × 2 factorial design, we examined the effect of exercise and behavioural recommendations on metabolic variables, and maternal/neonatal outcomes in 200 GDM patients. All women were given the same diet: group D received dietary recommendations only; group E was advised to briskly walk 20-min/day; group B received behavioural dietary recommendations; group BE was prescribed the same as B + E. Dietary habits improved in all groups. In a multivariable regression model, fasting glucose did not change. Exercise, but not behavioural recommendations, was associated with the reduction of postprandial glucose (p
Non-Medical Strategies to Improve Pregnancy Outcomes of Women with Gestational Diabetes Mellitus: A literature review. [2020]This review aimed to examine the literature related to non-medical strategies used to improve pregnancy outcomes of women with gestational diabetes mellitus (GDM) and to determine the risk of bias of the selected studies. Treatment for GDM is changing due to the increased prevalence of GDM-related maternal and neonatal complications. A growing body of evidence suggests that early detection, aggressive monitoring and management of GDM using non-medical strategies can greatly improve outcomes for pregnant women and their babies. PubMed® (National Library of Medicine, Bethesda, Maryland, USA), Cumulative Index to Nursing and Allied Health Literature® (EBSCO Information Services, Ipswich, Massachusetts, USA), SCOPUS® (Elsevier, Amsterdam, Netherlands) and other electronic databases were searched for relevant literature published between 2005-2015. A total of 15 studies on women with GDM that met the inclusion criteria were included in this review and assessment of risk of bias was performed for each study. The results of the studies were consistent with findings of significant improvement in maternal and neonatal outcomes when diet was combined with moderate exercise, self-monitoring of blood glucose and individualised health education. Future intervention studies in this area should be focussed on identifying and implementing factors that enhance and encourage adherence to the healthy behaviours mentioned above.
Effects of Diet and Exercise on Insulin Resistance during Pregnancy. [2022]Current evidence suggests that both diet and exercise can alter the usual increase in insulin resistance seen in Western societies during mid and late pregnancy. A low-glycemic diet combined with a low-volume exercise regimen during pregnancy decreases the glucose and insulin response to both mixed caloric intake and exercise, and probably lowers both 24-h blood glucose concentrations and the maternal substrate utilization ratio of carbohydrate/fat. The end result is a marked decrease in both maternal weight gain and size at birth. Regular weight-bearing exercise alone lowers markers of insulin resistance and lowers blood glucose concentration during and immediately after exercise during pregnancy. Changes in diet and/or physical activity appear to prevent the onset of gestational diabetes mellitus in at-risk women and may be of value in the treatment of those who develop gestational diabetes.
Investigation of a lifestyle change strategy for high-risk women with a history of gestational diabetes. [2022]Fifty-nine women with recent gestational diabetes participated in a randomized controlled trial to assess the feasibility and efficacy of a pragmatic diabetes risk reduction intervention. Intervention participants achieved improvements in energy, total and saturated fats, and carbohydrate intake, but no change in physical activity. Recruitment was challenging and below expectations.
Nutrition-Education-Based Interventions in Gestational Diabetes: A Scoping Review of Clinical Trials. [2023]Cases of diabetes mellitus have seen a global increase in prevalence, but there are inherent differences in the pathology and management of different types of diabetes. Type 2 and gestational diabetes have the most similar pathophysiology. For that reason, many similar management strategies exist between type 2 and gestational diabetes, including nutrition-based interventions. Diabetes self-management education and medical nutrition therapy have been advanced as cost-effective interventions to manage hyperglycemia. Many of these interventions, however, were designed for type 2 diabetes and adapted for diabetes in gestation. Nutrition-education-based interventions in gestational diabetes have not been fully elucidated. We scrutinized this gap by conducting a scoping review of recently published peer-reviewed studies that evaluated clinical endpoints in cases of gestational diabetes with nutrition-education-based interventions. The search yielded 621 articles, and the 12 articles included were published between 2012 and 2022. The nutrition information varied across the heterogeneous diabetes self-management education, whereas the medical nutrition therapy studies were more consistent. Our literature search revealed similar outcomes across self-management education and medical nutrition therapy interventions implemented during the third trimester of pregnancies with diabetes. These results suggest that both generalized and personalized approaches to nutrition education in gestational diabetes can manage hyperglycemia and offset its adverse consequences.
A lifestyle intervention of weight-gain restriction: diet and exercise in obese women with gestational diabetes mellitus. [2022]This study assessed whether a weight-gain restriction regimen, with or without exercise, would impact glycemic control, pregnancy outcome, and total pregnancy weight gain in obese subjects with gestational diabetes mellitus (GDM). A total of 96 subjects with GDM met the inclusion criteria and were sequentially recruited, with 39 subjects self-enrolled in the exercise and diet (ED) group, and the remaining 57 subjects self-enrolled in the diet (D) group owing to contraindications or a lack of personal preference to exercise. All patients were provided a eucaloric or hypocaloric consistent carbohydrate meal plan and instructed in the self-monitoring of blood glucose. In addition, all ED subjects were prescribed an exercise routine equivalent to a 60% symptom-limited VO2 max. Subjects were followed at weekly or biweekly office visits. Results showed maternal weight and body mass index (35.2+/-7.2 (ED) vs. 33.5+/-9.2 (D)) at study entry as well as number of weeks into the study (7.7+/-5.7 (ED) vs. 9.4+/-4.7 (D)) were similar in both the ED and D groups. Weight gain per week was significantly lower in the ED group than in the D group (0.1+/-0.4 kg vs. 0.3+/-0.4 kg; p
Effects of an Eating Pattern Including Colorful Fruits and Vegetables on Management of Gestational Diabetes: A Randomized Controlled Trial. [2023]Gestational diabetes mellitus (GDM), defined as abnormal glucose tolerance that presents during the second and third trimesters of pregnancy, is a growing issue in the United States and worldwide. If left untreated or poorly controlled, GDM can result in numerous consequences for both the mother and the fetus; thus, it is imperative that different avenues of management for GDM be explored. There is a paucity of studies that examine how lifestyle changes, including dietary and physical activity, affect management of GDM. We examined how counseling on lifestyle changes can affect cardiometabolic risks in women with GDM. We conducted a 12-week randomized controlled trial based on behavioral counseling in which women with GDM (N = 38) were randomized into either a nutrition education (control) (N = 18) group or nutrition intervention (N = 20) group. The nutrition education group were given dietary counseling regarding healthy dietary choices based on USDA guidelines, while the nutrition intervention group were instructed to consume a total of one cup of whole berries and one cup of leafy vegetables daily along with performing postprandial exercise (walking). Blood samples, anthropometric measures, and dietary and physical activity data, recorded in daily food and activity logs, were collected at baseline and at the end of the study and compared between the two groups. Dietary counseling on supplementation with whole berries and leafy vegetables resulted in increased fiber intake, increased antioxidant intake and total serum antioxidant capacity, improved random blood glucose, decreased serum IL-6, and improved HDL cholesterol versus the control group (all p < 0.05). These results highlight that whole berry and leafy vegetable supplementation-based dietary counseling can improve the metabolic pathways involved in gestational diabetes pathogenesis and prognosis. These functional foods must be recommended in the management of pregnancies affected by GDM.