Intervention Study: Genetic Risk Communication and Wearables

NCT04879758 | Unknown

• 1 other identifier: geneticriskwearabletrial
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the effects of communicating genetic risk for type 2 diabetes (T2D) alone or in combination with goal setting and prompts from a wearable device on objectively measured physical activity (PA) and sedentary behavior (SB) in East Asians. It is hypothesized that this combination will lead to significant favorable changes in objectively measured PA and SB, and that such changes will be more likely to be sustained over 6-month follow-up. This study aims to recruit 150 healthy East Asian adults in Hong Kong. At baseline, participants will be invited to visit the research laboratory for measurement of a series of variables including height, body weight, blood pressure and grip strength. Participants will also be invited to complete a set of questionnaires to assess their self-reported PA and SB, fruit and vegetable consumption, smoking status and psychological variables. Blood samples will be collected to analyze key diabetes and cardiovascular disease biochemical markers as well as their estimated genetic risk of T2D. Each individual's unique genetic risk for T2D will be estimated on the basis of established genetic variants associated with T2D specifically for East Asians. Each participant will be asked to wear a Fitbit Charge 4 tracker, an objective activity monitoring device, throughout the entire trial. Participants will be randomly allocated into 3 groups: 1 control and 2 intervention groups. A control group will receive an e-leaflet containing general lifestyle advice for prevention of T2D. An intervention group will receive an estimated genetic risk of T2D, in addition to the e-leaflet. The other intervention group will have a Fitbit step goal set 10% higher than their baseline step count and use prompt functions of the Fitbit tracker, in addition to the genetic risk estimate and e-leaflet. Activity data from the Fitbit will be collected at 4-week post-intervention; information about lifestyle and psychological variables will be assessed through the questionnaires at both immediate and 4-week post-intervention. To determine the longer-term effect of the intervention, participants will be asked to visit the research laboratory 6 months after the intervention to repeat the same set of assessments as baseline, except the blood samples collected at 6-month follow-up are used only to analyze cardiometabolic risk profiles (not genetic risk). Activity levels will also be objectively measured using the Fitbit for 4 weeks.

Conditions

Fitness Trackers; Sedentary Behavior; Exercise; Genetic Predisposition to Disease; Type 2 Diabetes

Keywords

diabetes; physical activity; genetic risk; wearable technology; randomized controlled trial; movement behavior; nutrition

Outcome Measures

Primary Outcomes (6)

• Changes in Steps between baseline and 4-week post-intervention, and between baseline and 6-month follow-up

  Step count (per day) will be objectively measured by the Fitbit tracker.

  Baseline, 4-week post-intervention, 6-month follow-up

• Changes in Sedentary Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up

  Sedentary Minutes (per day) will be objectively measured by the Fitbit tracker.

  Baseline, 4-week post-intervention, 6-month follow-up

• Changes in Lightly Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up

  Lightly Active Minutes (per day) will be objectively measured by the Fitbit tracker.

  Baseline, 4-week post-intervention, 6-month follow-up

• Changes in Fairly Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up

  Fairly Active Minutes (per day) will be objectively measured by the Fitbit tracker.

  Baseline, 4-week post-intervention, 6-month follow-up

• Changes in Very Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up

  Very Active Minutes (per day) will be objectively measured by the Fitbit tracker.

  Baseline, 4-week post-intervention, 6-month follow-up

• Changes in Calories Burn between baseline and 4-week post-intervention, and between baseline and 6-month follow-up

  Calories Burn (kcal per day) will be objectively measured by the Fitbit tracker.

  Baseline, 4-week post-intervention, 6-month follow-up

Secondary Outcomes (13)

• Changes in body mass index (BMI) between baseline and 6-month follow-up

  Baseline and 6-month follow-up

• Changes in systolic blood pressure between baseline and 6-month follow-up

  Baseline and 6-month follow-up

• Changes in diastolic blood pressure between baseline and 6-month follow-up

  Baseline and 6-month follow-up

• Changes in hand grip strength between baseline and 6-month follow-up

  Baseline and 6-month follow-up

• Changes in Hemoglobin A1c (HbA1c) between baseline and 6-month follow-up

  Baseline and 6-month follow-up

Study Arms (3)

Control Group

NO INTERVENTION

The control group will receive a Fitbit device and general lifestyle advice e-leaflet, which includes information about T2D, health impacts of T2D and lifestyle advice on 4 major risk markers of T2D (e.g., PA, diet, smoking, weight management) as recommended by the World Health Organization.

Intervention Group - Genetic Risk Estimate

EXPERIMENTAL

This intervention group will receive an estimated genetic risk of T2D in addition to the Fitbit and e-leaflet.

Genetic: Genetic Risk Estimate

Intervention Group - Genetic Risk Estimate + Fitbit Functions

EXPERIMENTAL

This intervention group will receive a Fitbit device, but have a Fitbit step goal set 10% higher than their baseline step count, and use its prompt functions, in addition to the genetic risk estimate and e-leaflet.

Other: Genetic Risk Estimate + Fitbit Functions

Interventions

Genetic Risk Estimate GENETIC

The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for T2D as well as a dichotomized genetic risk category: 'increased genetic risk' (if their genetic risk is higher than the average population risk) or 'no increased genetic risk' (if their genetic risk is not higher than the average population risk).

Intervention Group - Genetic Risk Estimate

Genetic Risk Estimate + Fitbit Functions OTHER

The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for T2D as well as a dichotomized genetic risk category: 'increased genetic risk' (if their genetic risk is higher than the average population risk) or 'no increased genetic risk' (if their genetic risk is not higher than the average population risk). The two unique Fitbit functions are step goal setting and prompts. Individualized daily step goals will be set to be 10% higher than participants' own baseline Fitbit step counts. The 'Reminder To Move' function of Fitbit will be used as a prompt to remind participants to reduce sedentary time and walk at least 250 steps/hour within a specified timeframe (i.e., from 9am to 10pm in the proposed research). If the user has not accumulated at least 250 steps/hour, a reminder (for example, 150 steps to go) will appear on the Fitbit screen at 10 minutes before the hour (for example, at 10:50 a.m.) and cause the device to vibrate.

Intervention Group - Genetic Risk Estimate + Fitbit Functions

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• East Asian ancestry
• Aged 40-60 years
• Able to perform daily-living physical activity
• Able to use English to communicate
• Use a smartphone

You may not qualify if:

• have been diagnosed with any type of diabetes
• pregnant or lactating
• unable to perform daily-life physical activities (determined through Physical Activity Readiness Questionnaire \[PAR-Q\])
• participating in another research study or exercise programs
• had experience of genetic testing
• cannot use English

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Exercise Physiology Lab, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity; Genetic Predisposition to Disease; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Behavior; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Youngwon Kim

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youngwon Kim

CONTACT

(+852)28315252; youngwon.kim@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Group allocation will be concealed from study staff until the 7-day pre-intervention period begins (for preparation of corresponding e-leaflets, genetic risk estimates and/or baseline Fitbit step goal calculations), and from participants until the interventions are delivered. Given the nature of the interventions delivered, it will be impossible for participants to be blinded to the specific intervention they receive once the initial interventions are provided; however, study staff analyzing participants' de-identified data will remain blinded to participant randomization assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: parallel-group, open randomized controlled trial

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 10, 2021
• Study Start: July 7, 2021
• Primary Completion: December 1, 2023
• Study Completion: May 1, 2024
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

HK (1)