More Health Less Diabetes

NCT07079722 | Recruiting

• 1 other identifier: MHLD FMH
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The "More Health, Less Diabetes" project is a hybrid randomized controlled trial to prevent type 2 diabetes in individuals at risk through structured exercise and lifestyle education. While exercise benefits for people with diabetes are well-documented, evidence remains limited on the effectiveness and cost-effectiveness of in-person and home-based exercise programs in a prediabetic population. This study aims to understand the clinical and cost-effectiveness of a three-arm RCT (online, in-person, and a control group) in people at high risk of developing T2DM. This 12-month program includes six months of supervised exercise (3 times/week) and a six-month follow-up. During the first six months, both intervention groups will attend educational sessions to improve health literacy and promote healthy habits. The primary outcome will be 2h glycemia in an oral glucose tolerance test. Secondary outcomes include other aspects of glycemic control (HbA1c, fasting glycemia, HOMA-IR, Matsuda index), 24-hour movement, body composition, vascular health, physical fitness, and cost-effectiveness using a social return on investment approach.

Conditions

Pre-diabetes

Keywords

Diabetes; Exercise; Community programs; Prevention; Health

Outcome Measures

Primary Outcomes (1)

• 2-hour glucose tolerance test (OGTT)

  Biochemical assessments will be conducted through primary healthcare centers. Participants will undergo clinical analyses of a 2-hour glucose tolerance test (OGTT) after ingesting 75g of glucose at baseline, after six months, and after one year.

  1 year

Secondary Outcomes (22)

• Height in centimeters

  1 year

• Weight in kilograms

  1 year

• Body Mass Index

  1 year

• Effectiveness of the program

  Through study completion, an average of 1 year

• Costs of the program

  Through study completion, an average of 1 year

Study Arms (3)

Control group

ACTIVE COMPARATOR

The control group will not participate in educational sessions or structured physical exercise.

Behavioral: Exercise

In-person intervention group (IIG).

EXPERIMENTAL

The IIG will participate in in-person educational sessions and supervised physical exercise

Behavioral: Exercise

Online intervention group (OIG)

EXPERIMENTAL

The OIG will receive online educational sessions and structured home-based exercises

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

This project is a randomized controlled trial (RCT) with three distinct groups: a control group (CG), an online intervention group (OIG), and an in-person intervention group (IIG). The OIG will receive online educational sessions and structured home-based exercises, while the IIG will participate in in-person educational sessions and supervised physical exercise. The control group will not participate in educational sessions or structured physical exercise.

Control group; In-person intervention group (IIG).; Online intervention group (OIG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High or Very High Risk according to the FINDRISC questionnaire;
• Analytical confirmation of no diagnostic criteria for Diabetes, following a type 2 Diabetes risk assessment;
• Committed to making lifestyle changes to manage diabetes;
• Internet access;
• Availability to participate in the program as required (schedule, location);

You may not qualify if:

• pregnancy (self-report/medical record);
• Inability to use digital devices
• Presence of abnormalities on exercise stress test.

Sponsors & Collaborators

• Faculdade de Motricidade Humana: lead

Study Sites (1)

Faculty of Human Kinetics

Lisbon, Lisbon District, 1499-002, Portugal

RECRUITING

Related Publications (20)

• Diabetes Prevention Program Research Group. Long-term effects of lifestyle intervention or metformin on diabetes development and microvascular complications over 15-year follow-up: the Diabetes Prevention Program Outcomes Study. Lancet Diabetes Endocrinol. 2015 Nov;3(11):866-75. doi: 10.1016/S2213-8587(15)00291-0. Epub 2015 Sep 13.

  PMID: 26377054 BACKGROUND

• Magliano DJ, Boyko EJ; IDF Diabetes Atlas 10th edition scientific committee. IDF DIABETES ATLAS [Internet]. 10th edition. Brussels: International Diabetes Federation; 2021. Available from http://www.ncbi.nlm.nih.gov/books/NBK581934/

  PMID: 35914061 BACKGROUND

• Al Ozairi E, Alsaeed D, Al Roudhan D, Jalali M, Mashankar A, Taliping D, Abdulla A, Gill JMR, Sattar N, Welsh P, Gray SR. The effect of home-based resistance exercise training in people with type 2 diabetes: A randomized controlled trial. Diabetes Metab Res Rev. 2023 Oct;39(7):e3677. doi: 10.1002/dmrr.3677. Epub 2023 Jun 17.

  PMID: 37330638 BACKGROUND

• Dunstan DW, Daly RM, Owen N, Jolley D, Vulikh E, Shaw J, Zimmet P. Home-based resistance training is not sufficient to maintain improved glycemic control following supervised training in older individuals with type 2 diabetes. Diabetes Care. 2005 Jan;28(1):3-9. doi: 10.2337/diacare.28.1.3.

  PMID: 15616225 BACKGROUND

• Dunstan DW, Vulikh E, Owen N, Jolley D, Shaw J, Zimmet P. Community center-based resistance training for the maintenance of glycemic control in adults with type 2 diabetes. Diabetes Care. 2006 Dec;29(12):2586-91. doi: 10.2337/dc06-1310.

  PMID: 17130189 BACKGROUND

• Golovaty I, Wadhwa S, Fisher L, Lobach I, Crowe B, Levi R, Seligman H. Reach, engagement and effectiveness of in-person and online lifestyle change programs to prevent diabetes. BMC Public Health. 2021 Jul 5;21(1):1314. doi: 10.1186/s12889-021-11378-4.

  PMID: 34225674 BACKGROUND

• Correia IR, Hetherington-Rauth M, Magalhaes JP, Judice PB, Rosa GB, Henriques-Neto D, Manas A, Ara I, Silva AM, Sardinha LB. Compensatory mechanisms from different exercise intensities in type 2 diabetes: a secondary analysis of a 1-year randomized controlled trial. Acta Diabetol. 2023 May;60(5):645-654. doi: 10.1007/s00592-023-02038-7. Epub 2023 Feb 2.

  PMID: 36729308 BACKGROUND

• Magalhaes JP, Hetherington-Rauth M, Judice PB, Correia IR, Rosa GB, Henriques-Neto D, Melo X, Silva AM, Sardinha LB. Interindividual Variability in Fat Mass Response to a 1-Year Randomized Controlled Trial With Different Exercise Intensities in Type 2 Diabetes: Implications on Glycemic Control and Vascular Function. Front Physiol. 2021 Sep 16;12:698971. doi: 10.3389/fphys.2021.698971. eCollection 2021.

  PMID: 34603073 BACKGROUND

• Mendes R, Sousa N, Reis VM, Themudo-Barata JL. Implementing Low-Cost, Community-Based Exercise Programs for Middle-Aged and Older Patients with Type 2 Diabetes: What Are the Benefits for Glycemic Control and Cardiovascular Risk? Int J Environ Res Public Health. 2017 Sep 13;14(9):1057. doi: 10.3390/ijerph14091057.

  PMID: 28902144 BACKGROUND

• Magalhaes JP, Melo X, Correia IR, Ribeiro RT, Raposo J, Dores H, Bicho M, Sardinha LB. Effects of combined training with different intensities on vascular health in patients with type 2 diabetes: a 1-year randomized controlled trial. Cardiovasc Diabetol. 2019 Mar 18;18(1):34. doi: 10.1186/s12933-019-0840-2.

  PMID: 30885194 BACKGROUND

• Magalhaes JP, Judice PB, Ribeiro R, Andrade R, Raposo J, Dores H, Bicho M, Sardinha LB. Effectiveness of high-intensity interval training combined with resistance training versus continuous moderate-intensity training combined with resistance training in patients with type 2 diabetes: A one-year randomized controlled trial. Diabetes Obes Metab. 2019 Mar;21(3):550-559. doi: 10.1111/dom.13551. Epub 2018 Oct 29.

  PMID: 30284352 BACKGROUND

• Hetherington-Rauth M, Magalhaes JP, Judice PB, Melo X, Sardinha LB. Vascular improvements in individuals with type 2 diabetes following a 1 year randomised controlled exercise intervention, irrespective of changes in cardiorespiratory fitness. Diabetologia. 2020 Apr;63(4):722-732. doi: 10.1007/s00125-020-05089-5. Epub 2020 Jan 20.

  PMID: 31960071 BACKGROUND

• Magalhaes JP, Santos DA, Correia IR, Hetherington-Rauth M, Ribeiro R, Raposo JF, Matos A, Bicho MD, Sardinha LB. Impact of combined training with different exercise intensities on inflammatory and lipid markers in type 2 diabetes: a secondary analysis from a 1-year randomized controlled trial. Cardiovasc Diabetol. 2020 Oct 7;19(1):169. doi: 10.1186/s12933-020-01136-y.

  PMID: 33028418 BACKGROUND

• Hamman RF, Wing RR, Edelstein SL, Lachin JM, Bray GA, Delahanty L, Hoskin M, Kriska AM, Mayer-Davis EJ, Pi-Sunyer X, Regensteiner J, Venditti B, Wylie-Rosett J. Effect of weight loss with lifestyle intervention on risk of diabetes. Diabetes Care. 2006 Sep;29(9):2102-7. doi: 10.2337/dc06-0560.

  PMID: 16936160 BACKGROUND

• Barbosa A, Brito J, Figueiredo P, Seabra A, Ding D, Mendes R. How much does it cost to implement a community-based walking football programme for patients with type 2 diabetes? BMJ Open Sport Exerc Med. 2023 Jun 7;9(2):e001549. doi: 10.1136/bmjsem-2023-001549. eCollection 2023.

  PMID: 37304893 BACKGROUND

• Green DJ, Hopman MT, Padilla J, Laughlin MH, Thijssen DH. Vascular Adaptation to Exercise in Humans: Role of Hemodynamic Stimuli. Physiol Rev. 2017 Apr;97(2):495-528. doi: 10.1152/physrev.00014.2016.

  PMID: 28151424 BACKGROUND

• Wasserman DH, Wang TJ, Brown NJ. The Vasculature in Prediabetes. Circ Res. 2018 Apr 13;122(8):1135-1150. doi: 10.1161/CIRCRESAHA.118.311912.

  PMID: 29650631 BACKGROUND

• Ligthart S, van Herpt TT, Leening MJ, Kavousi M, Hofman A, Stricker BH, van Hoek M, Sijbrands EJ, Franco OH, Dehghan A. Lifetime risk of developing impaired glucose metabolism and eventual progression from prediabetes to type 2 diabetes: a prospective cohort study. Lancet Diabetes Endocrinol. 2016 Jan;4(1):44-51. doi: 10.1016/S2213-8587(15)00362-9. Epub 2015 Nov 11.

  PMID: 26575606 BACKGROUND

• Beulens J, Rutters F, Ryden L, Schnell O, Mellbin L, Hart HE, Vos RC. Risk and management of pre-diabetes. Eur J Prev Cardiol. 2019 Dec;26(2_suppl):47-54. doi: 10.1177/2047487319880041.

  PMID: 31766914 BACKGROUND

• Diabetologia SPd. Diabetes: Factos e Números- O ano de 2019, 2020 e 2021- Relatório Anual do Observatório Nacional de Diabetes. 2023.

  BACKGROUND

MeSH Terms

Conditions

Glucose Intolerance; Diabetes Mellitus; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

João Magalhães Associate Professor, Doctor

CONTACT

967 832 539; joaomagalhaes@fmh.ulisboa.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The "More Health, Less Diabetes" research project is a randomized controlled trial (RCT) with three distinct groups: a control group (CG), an online intervention group (OIG), and an in-person intervention group (IIG). The OIG will receive online educational sessions and structured home-based exercises, while the IIG will participate in in-person educational sessions and supervised physical exercise. The control group will not participate in educational sessions or structured physical exercise.

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: July 23, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-05

Locations

PT (1)