Family-based Prevention of Diabetes Through Eating Habits and Physical Activity

NCT05694351 | Completed

• 1 other identifier: 96452
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Type 2 diabetes represents a growing health risk for the society. An easy-access and low-cost intervention for the whole family will be developed to help families with (at risk of) type 2 diabetes maintain diabetes-frendly everyday life. The intervention will be tested for feasibility. Methods: Following the framework for developing and conduct of complex interventions, the intervention will be developed on the basis of current evidence on family-based diabetes treatment and opinions of families with type 2 diabetes. The feasibility test will have embedded mixed methods one-group study design. Participants: Families will answer a brief screening questionnaire. Families (n=25) that consist of at least one adult with (in risk of) type 2 diabetes living in the same household with at least one 5-18 yeard old child, and at least one family member living sedentary lifestyle, will participate. Intervention: The 3-months long hybrid telehealth/face-to-face intervention with weekly 1-hour contacts with health professionals will deliver diabetes education and tailored support to implement more physical activity and healthy meals in the family everyday life. A 3-months long supervised maintenance phase with monthly professional contacts will be included. Outcomes: Feasibility evaluation will be conducted using quantitative (quantifiable) and qualitative research methods. The feasibility data will be the primary outcomes of the study, collected and evaluated using the predefined research progression criteria applied the green-amber-red method. Sociodemography and secondary outcomes, such as physical activity, dieting habits, daily occupations, occupational balance, health and quality of life will be assessed at baseline and 3 and 6-months follow-ups. The quantitative results will be comprehended through qualitative data from participant interviews which will nuance the feasibility evaluation. Analysis: Relevant statistical methods and qualitative analysis method will be applied. Expected results: The intervention will help families achieve sustainable lifestyle changes, e.g., diabetes stabilized blood glucose in adults with type 2 diabetes, increased physical activity time and improved dieting habits, for better family health and well-being. Ethics and dissemination: The trial does not have any obvious health risks for the participants. All the results - significant, non-significant and/ or inconclusive - will be reported.

Conditions

Diabetes Mellitus, Type 2; Family Health; Health Behavior; Healthy Lifestyle; Prediabetic State; Telemedicine

Outcome Measures

Primary Outcomes (22)

• Rate of the participants recruited per months

  cf. predefined research progression criteria

  3 months

• Rate of the participants recruited per months

  cf. predefined research progression criteria

  6 months

• Percentage of participants completed the intervention

  cf. predefined research progression criteria

  3 months

• Percentage of participants completed the intervention

  cf. predefined research progression criteria

  6 months

• Rate of participants' adherence to the intervention's sessions (attendance registration forms)

  cf. predefined research progression criteria

  3 months

• Rate of participants' adherence to the intervention's sessions (attendance registration forms)

  cf. predefined research progression criteria

  6 months

• Participants' self-perceived relevance (questionnaire, 5-items Likert scale, higher score is best)

  cf. predefined research progression criteria

  3 months

• Participants' self-perceived relevance (questionnaire, 5-items Likert scale, higher score is best)

  cf. predefined research progression criteria

  6 months

• Participants' self-perceived timing (questionnaire, 5-items Likert scale, higher score is best)

  cf. predefined research progression criteria

  3 months

• Participants' self-perceived timing (questionnaire, 5-items Likert scale, higher score is best)

  cf. predefined research progression criteria

  6 months

• Participants' self-perceived mode of delivery (questionnaire, 5-items Likert scale, higher score is best)

  cf. predefined research progression criteria

  3 months

• Participants' self-perceived mode of delivery (questionnaire, 5-items Likert scale, higher score is best)

  cf. predefined research progression criteria

  6 months

• Satisfaction with the treatment (questionnaire, 5-items Likert scale, higher score is best)

  cf. predefined research progression criteria

  3 months

• Satisfaction with the treatment (questionnaire, 5-items Likert scale, higher score is best)

  cf. predefined research progression criteria

  6 months

• Assessment procedure acceptance (questionnaire, 5-items Likert scale, higher score is best)

  cf. predefined research progression criteria

  3 months

• Assessment procedure acceptance (questionnaire, 5-items Likert scale, higher score is best)

  cf. predefined research progression criteria

  6 months

• Adverse events

  cf. predefined research progression criteria

  3 months

• Adverse events

  cf. predefined research progression criteria

  6 months

• Fidelity of delivery (questionnaire, 5-items Likert scale, higher score is best)

  cf. predefined research progression criteria

  3 months

• Fidelity of delivery (questionnaire, 5-items Likert scale, higher score is best)

  cf. predefined research progression criteria

  6 months

• Contextual appropriateness (questionnaire, 5-items Likert scale, higher score is best)

  Treatment acceptance, cf. predefined research progression criteria

  3 months

• Contextual appropriateness (questionnaire, 5-items Likert scale, higher score is best)

  Treatment acceptance, cf. predefined research progression criteria

  6 months

Secondary Outcomes (11)

• Weekly physical activity, self-reported

  Change from baseline to 6 months

• Daily wake-time physical activity, objective

  Change from baseline to 6 months

• Daily walking steps, objective

  Change from baseline to 6 months

• Dieting habits

  Change from baseline to 6 months

• Glucaemic control

  Change from baseline to 6 months

Study Arms (1)

Families with type 2 diabetes

EXPERIMENTAL

Families (n=25) of at least two family members - minimum one adult and one child per family unit (appx. 100 individuals in total) will be included. A convenient study sample will be composed with no restriction to family types - traditional nuclear families, same-sex parenting families, single-parent families, or blended/ step-parent families). Balanced representation of different geographical areas within Region Zealand will be attempted.

Behavioral: Healthy meals and physical activity in families with type 2 diabetes

Interventions

Healthy meals and physical activity in families with type 2 diabetes BEHAVIORAL

Families will participate in telehealth family education on diabetes management and prevention through lifestyle modifications in their everyday occupations regarding current recommendations for physical activity, grocery shopping, meal preparation, and family meal routines. Each family will be assisted in setting tailored goals for the family as a whole and individually regarding physical activity and dieting habits. The goals will be incorporated into family daily routines, to secure manageability and sustainability of the new lifestyle habits. Local facilities and communy networks will be engaged in this process to empower and motivate the participants. Working with the goals will be monitored and facilitated throughout the intervention period of 3 months. Before discharge, each family will co-produce a maintenance plan for physical activity and healthy dieting.

Also known as: GO EASY: God ernæring og aktivitet for nye synergier i familier i Region Sjælland

Families with type 2 diabetes

Eligibility Criteria

• Age: 5 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents (aged 18 or older) with (or at risk of) type 2 diabetes living in the same household with 5-17 years old children
• At least one family member not meeting the current physical activity recommendations.

You may not qualify if:

• Pregnancy or postpartum period (6 months after birth)
• Current critical illness, e.g. cancer
• Participating in other type 2 diabetes treatment programs

Sponsors & Collaborators

• Slagelse Hospital: lead

Study Sites (1)

Svetlana Solgaard Nielsen

Slagelse, 4200, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Health Behavior; Prediabetic State

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; 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

Study Officials

• Svetlana Solgaard Nielsen, PhD

  Slagelse Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Occupational Therapist, PhD, postdoc

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 23, 2023
• Study Start: January 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)