Effect of Strength-resistance Exercise in the Reduction of Gestational Diabetes in Pregnant Women with Overweight or Obesity

NCT05840497 | Recruiting

• 1 other identifier: PI_2022/126
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to test the efficacy of regular resistance exercise in early pregnancy to prevent gestational diabetes mellitus in overweight/ obese pregnant women.

Conditions

Diabetes, Gestational

Keywords

Exercise; Weight gain; Pregnant; Obese; Overweight

Outcome Measures

Primary Outcomes (1)

• Gestational diabetes

  Gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance with onset or first recognition during pregnancy: * O'Sullivan Test: if this is pathological; * SOG with 100 gr of glucose (GDM is diagnosed when 2 or more altered values: basal glycemia \>105 mg / dl, at 1 hour \>190 mg / dl, at 2h glycemia \>165 mg / dl, at 3h glycemia \>145 gr/dl).

  24-28 gestational weeks

Secondary Outcomes (2)

• Weight gain and excessive body weight gain

  From baseline visit to the third trimester visit

• Maternal and fetal pregnancy outcomes

  At birth

Study Arms (2)

Resistance exercise

EXPERIMENTAL

Other: Resistance exercise

Control Group

NO INTERVENTION

Standard control and usual recommendations.

Interventions

Resistance exercise OTHER

The intervention group will train 3 times per week (30 minutes with 15 min warm-up). The resistance exercise is described as the voluntary contraction of the skeletal muscle of a particular muscle group against some type of resistance, using light weights, elastic bands or the weight of the body itself. Patients will be offered online sessions, they will receive a document with recommendations and a link to the videos with instructions. .

Resistance exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI≥25 kg/m2
• Singleton pregnancies

You may not qualify if:

• Chronic hypertension
• Pre-pregnancy DM (type I or 2 diabetes mellitus)
• Cardiovascular disease
• History of preterm delivery

Sponsors & Collaborators

• Fundacion Miguel Servet: lead

Study Sites (1)

Fundación Miguel Servet/Navarrabiomed

Pamplona, Navarre, Spain

RECRUITING

Related Publications (10)

• Bhattacharya S, Campbell DM, Liston WA, Bhattacharya S. Effect of Body Mass Index on pregnancy outcomes in nulliparous women delivering singleton babies. BMC Public Health. 2007 Jul 24;7:168. doi: 10.1186/1471-2458-7-168.

  PMID: 17650297 BACKGROUND

• Xu MY, Guo YJ, Zhang LJ, Lu QB. Effect of individualized weight management intervention on excessive gestational weight gain and perinatal outcomes: a randomized controlled trial. PeerJ. 2022 Mar 8;10:e13067. doi: 10.7717/peerj.13067. eCollection 2022.

  PMID: 35282280 BACKGROUND

• Roberts JM, Bodnar LM, Patrick TE, Powers RW. The Role of Obesity in Preeclampsia. Pregnancy Hypertens. 2011 Jan 1;1(1):6-16. doi: 10.1016/j.preghy.2010.10.013.

  PMID: 21532964 BACKGROUND

• Domingues MR, Bassani DG, da Silva SG, Coll Cde V, da Silva BG, Hallal PC. Physical activity during pregnancy and maternal-child health (PAMELA): study protocol for a randomized controlled trial. Trials. 2015 May 24;16:227. doi: 10.1186/s13063-015-0749-3.

  PMID: 26003406 BACKGROUND

• Fair F, Soltani H. A meta-review of systematic reviews of lifestyle interventions for reducing gestational weight gain in women with overweight or obesity. Obes Rev. 2021 May;22(5):e13199. doi: 10.1111/obr.13199. Epub 2021 Jan 18.

  PMID: 33459493 BACKGROUND

• Magro-Malosso ER, Saccone G, Di Mascio D, Di Tommaso M, Berghella V. Exercise during pregnancy and risk of preterm birth in overweight and obese women: a systematic review and meta-analysis of randomized controlled trials. Acta Obstet Gynecol Scand. 2017 Mar;96(3):263-273. doi: 10.1111/aogs.13087.

  PMID: 28029178 BACKGROUND

• Petrov Fieril K, Glantz A, Fagevik Olsen M. The efficacy of moderate-to-vigorous resistance exercise during pregnancy: a randomized controlled trial. Acta Obstet Gynecol Scand. 2015 Jan;94(1):35-42. doi: 10.1111/aogs.12525. Epub 2014 Nov 13.

  PMID: 25287282 BACKGROUND

• Barakat R, Ruiz JR, Stirling JR, Zakynthinaki M, Lucia A. Type of delivery is not affected by light resistance and toning exercise training during pregnancy: a randomized controlled trial. Am J Obstet Gynecol. 2009 Dec;201(6):590.e1-6. doi: 10.1016/j.ajog.2009.06.004. Epub 2009 Jul 15.

  PMID: 19608151 BACKGROUND

• Xie Y, Zhao H, Zhao M, Huang H, Liu C, Huang F, Wu J. Effects of resistance exercise on blood glucose level and pregnancy outcome in patients with gestational diabetes mellitus: a randomized controlled trial. BMJ Open Diabetes Res Care. 2022 Apr;10(2):e002622. doi: 10.1136/bmjdrc-2021-002622.

  PMID: 35383101 BACKGROUND

• Wang C, Wei Y, Zhang X, Zhang Y, Xu Q, Sun Y, Su S, Zhang L, Liu C, Feng Y, Shou C, Guelfi KJ, Newnham JP, Yang H. A randomized clinical trial of exercise during pregnancy to prevent gestational diabetes mellitus and improve pregnancy outcome in overweight and obese pregnant women. Am J Obstet Gynecol. 2017 Apr;216(4):340-351. doi: 10.1016/j.ajog.2017.01.037. Epub 2017 Feb 1.

  PMID: 28161306 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Motor Activity; Weight Gain; Obesity; Overweight

Interventions

Resistance Training

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; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Teresa Santa Cruz Sarasqueta

CONTACT

689203204; te.santa.cruz@navarra.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 3, 2023
• Study Start: March 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: September 30, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)