NCT02686502

Brief Summary

This study evaluates the effect and usability of mobile and cloud technology -based intervention on lifestyle modification in 18-40 year obese and overweight subjects. The study has a dose-response design with three randomized subjects groups from Mode 1 to Mode 3 with increasing intensity of intervention (guidance, exercise program, diet, support). The special focus of this study is on motivation and use of music and mobile health devices as motivational tools to support individualized exercise training, healthy diet and overall healthy life style.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 19, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

3.7 years

First QC Date

January 22, 2016

Last Update Submit

May 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from measured baseline maximal O2 uptake (VO2max) at 3 months

    3 months

Secondary Outcomes (169)

  • Change from baseline quality of life at 3 months

    3 months

  • Change from baseline total plasma cholesterol at 3 months

    3 months

  • Change from baseline physical activity at 3 months

    3 months

  • Change from baseline body weight at 3 months

    3 months

  • Change from baseline quality of life at 1 year

    1 year

  • +164 more secondary outcomes

Study Arms (3)

Mode 1

NO INTERVENTION

Current guidelines. Subjects attending the examinations and the tests but not participating the individualized intervention. The subjects will receive general guidance on healthy exercise and diet.

Mode 2

ACTIVE COMPARATOR

Individualized lifestyle intervention. Exercise intervention will be based on submaximal ergometer test (estimated VO2max), clinical status, personal goals and preferences. Intervention also includes diet counseling, multiprofessional team support, peer support and use of mobile health applications.

Behavioral: Lifestyle

Mode 3

ACTIVE COMPARATOR

Highly individual lifestyle intervention. In addition to Mode 2 arm intervention optimal intensity zones and volumes for individual exercise training will be determined based on advanced cardiopulmonary exercise test.

Behavioral: Lifestyle

Interventions

LifestyleBEHAVIORAL

As part of the intervention Mode 2 and 3 subjects will use various mobile health applications including heart rate monitor, global positioning system, diet diary, and weight, sleep and mood monitors. They will also be offered music streaming service for e.g. motivation and relaxation.

Also known as: Exercise, Diet
Mode 2Mode 3

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI ≥ 27,5 kg/m2
  • estimated by health care personnel to benefit from lifestyle modification

You may not qualify if:

  • inability to perform exercise testing and intervention (physical, mental or other reason)
  • not able to operate in Finnish (some applications only in Finnish for the time being)
  • severe anemia (Hb\<108 g/l for women and \< 124 g/l for men)
  • smoking (disturbs autonomic nervous system measurements)
  • regular medication affecting glucose metabolism (excluding insulin) or autonomic nervous system (e.g. beta blockers, SSRI)
  • ongoing pregnancy or breast feeding
  • prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Helsinki University Hospital

Helsinki, Finland

Location

Vantaa Health Care and Social Services

Vantaa, Finland

Location

Related Publications (1)

  • Kaseva K, Tervaniemi M, Heikura E, Kostilainen K, Poyhonen-Alho M, Shoemaker JK, Petrella RJ, Peltonen JE. Identifying Personality Characteristics and Indicators of Psychological Well-Being Associated With Attrition in the Motivation Makes the Move! Physical Activity Intervention: Randomized Technology-Supported Trial. JMIR Form Res. 2022 Nov 25;6(11):e30285. doi: 10.2196/30285.

MeSH Terms

Conditions

ObesityCardiovascular DiseasesMotor Activity

Interventions

ExerciseDiet

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Seppo Heinonen, Professor

    HUCH, Dept. of Obstetrics and Gynecology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 22, 2016

First Posted

February 19, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

June 2, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations