Persistence of Physical Activity in People With Type 2 Diabetes Over Time.

NCT05661799 | Unknown

• 1 other identifier: PerPA2Temps
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Many programmes exist to enable patients to engage in physical activity, but it is clear that the objectives are often not achieved in terms of quality, quantity or intensity of practice. In this study, the aim is to find alternatives, assuming that strengthening patients' self-efficacy, meeting their basic needs and increasing their level of hope will have an impact on their motivation to practice, which in turn will have an impact on their actual practice. The aim is to develop and implement an innovative intervention programme and to identify the interactions between the variables that are assumed to predict engagement in practice.

Conditions

Diabetes Mellitus, Type 2; Physical Activity; Psychological

Outcome Measures

Primary Outcomes (1)

• Change in amount of physical activity assessed by the French Version of GPAQ

  The evolution of the quantity of physical activity will be the main criterion of judgment. It will be measured by the Global Physical Activity Questionnaire, which will allow for differentiation of intensities and contexts of practice. This questionnaire will be administered at each evaluation time proposed by the study (before/after, at 3, 6 and 12 months). The higher the score (in Metabolic Equivalent of Task/minutes/weeks), the greater the amount and intensity of physical activity performed. The comparison between the pre- and post-programme assessments (e.g. T0 and T1) will allow the direct effect of the programme on the amount of physical activity to be determined. The other assessments (e.g. T2, T3 and T4) will determine the persistence of this practice over time.

  Pre-intervention/immediately after the intervention, at 3, 6 and 12 months after the intervention

Secondary Outcomes (12)

• Change in the subjects' motivational profile towards a more self-determined motivation assessed by the French Version of the Motivation for Physical Activity for Health Scale

  Pre-intervention/immediately after the intervention, at 3, 6 and 12 months after the intervention

• Change in the satisfaction of basic psychological needs assessed by the French Version of The Basic Psychological Needs.

  Pre-intervention/immediately after the intervention, at 3, 6 and 12 months after the intervention

• Change in self-efficacy assessed by the French Version of The Self-Efficacy Questionnaire

  Pre-intervention/immediately after the intervention, at 3, 6 and 12 months after the intervention

• Change of initial state hope level assessed by the French Version of the State Hope Scale

  Pre-intervention/immediately after the intervention, at 3, 6 and 12 months after the intervention

• Change in dispositional hope level assessed by the French Version of the Adult Dispositional Hope Scale

  Pre-intervention/immediately after the intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

The proposed intervention consists of one hour of adapted physical activity per week for 12 weeks, led by a professional. In addition to this intervention, the intervention includes two 15-minute sessions, one before and one after the session. At the end of each session, a PA challenge and a positive reinforcement exercise will be proposed. The participants will have a week to try to achieve these. In addition to these two 15-minute sessions, participants will benefit from a one-and-a-half hour group session for information and experience sharing. The aim of this session is to discuss different topics related to diabetes.

Behavioral: Intervention Group

Control group

ACTIVE COMPARATOR

The proposed intervention consists of one hour of adapted physical activity per week for 12 weeks, led by a professional.

Behavioral: Control Group

Interventions

Intervention Group BEHAVIORAL

The programme is a PA programme consisting of one weekly session for 12 weeks. The one hour of PA is supplemented by two 15-minute periods. At the end of each session, a PA challenge and a positive reinforcement exercise are proposed for the coming week. At the beginning of the next session, the facilitator has a dedicated time to give feedback on these challenges (successes and difficulties encountered). At the end of each session, the facilitator explains the theme of the next challenge and exercise. For the challenge, three options are proposed. Each participant chooses the option he/she prefers. Positive reinforcement exercises are also offered in the same way. They aim to strengthen motivation, hope and the sense of self-efficacy (SEP). In addition to these two 15-minute sessions, participants are offered a one-and-a-half hour group session for information and experience sharing. The aim of this session is to discuss different themes.

Intervention Group

Control Group BEHAVIORAL

The programme is a PA programme consisting of one weekly session for 12 weeks.

Control group

Eligibility Criteria

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

You may qualify if:

• Subject over 18 years of age
• Subject who has given signed consent to participate in the protocol
• Type 2 diabetic subject not treated with insulin
• Subject participating for the first time in adapted physical activity sessions provided by Siel Bleu
• Subject understanding and reading French

You may not qualify if:

• Subjects with major health problems that prevent them from continuing the programme.
• Subjects who have withdrawn their consent.

Sponsors & Collaborators

• Siel Bleu: lead

Study Sites (1)

Elise Maudet-Coulomb

Angers, Maine Et Loire, 49000, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Elise Maudet-Coulomb, Ms

  Université de Lorraine, EA 4360 APEMAC, Metz, France

  PRINCIPAL INVESTIGATOR

• Charles Martin-Krumm, PhD

  Université de Lorraine, EA 4360 APEMAC, Metz, France

  STUDY CHAIR

• Jean-Christophe Mino, PhD

  Institut de recherche Siel Bleu, Paris France

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: December 22, 2022
• Study Start: September 9, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)