NCT02826122

Brief Summary

The Purpose of this study is to 1) investigate prevalence of diastolic dysfunction in patients with morbid obesity attending a conservative lifestyle change program, 2) investigate effects on cardiac function, cardiorespiratory Fitness, body composition, quality of life and cardiovascular risk through the program, 3) investigate feasibility of introducing two different activity monitors throughout the program, and 4) comparing compliance to activity sensor market leader FitBit Application versus Mio Pai Application

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

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

July 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

July 5, 2016

Last Update Submit

August 23, 2018

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • diastolic dysfunction

    echocardiac examination at baseline assessed by GE Healthcare Vivid E9, Horten, Norway

    18 months

Secondary Outcomes (71)

  • diastolic function

    4 months

  • diastolic function

    12 months

  • Cardiorespiratory fitness

    4 months

  • Cardiorespiratory fitness

    12 months

  • Cardiorespiratory fitness

    18 months

  • +66 more secondary outcomes

Other Outcomes (9)

  • Feasibility

    4 months

  • Feasibility

    12 months

  • Feasibility

    18 months

  • +6 more other outcomes

Study Arms (2)

FitBit APP

ACTIVE COMPARATOR

FitBit Zip APP registers and give feed-back on number of steps per day, distance and calories burned.

Device: FitBit APP

Pai APP

EXPERIMENTAL

Mio Pai APP registers duration and intensity of the Activity and give feed back as activity Points.

Device: Pai APP

Interventions

Pai APPDEVICE

Prescription: Target 100 PAI Points per week

Also known as: Personal Activity Intelligence (PAI) application, MIO Fuse Wristband
Pai APP
FitBit APPDEVICE

Prescription: Target daily 10.000 steps

Also known as: FitBit Zip
FitBit APP

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \> 40 kg/m2 (or BMI \> 35 kg/m2 with comorbidity)
  • Stable weight last Three months (≤ 2 kg variation)
  • Norwegian speaking
  • Smartphone

You may not qualify if:

  • Other weight reduction treatment, including medication affecting appetite
  • Known chronic cardiac condition
  • Previous bariatric surgery
  • Alcohol or other substitute abuse
  • Psychiatric disorder needing treatment, including eating disorders
  • Pregnancy or planned pregnancy during project period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LHL-Klinikkene

Røros, Norway

Location

Related Publications (1)

  • Oldervoll LM, Gjestad R, Hilmarsen C C, Ose A, Gullikstad L, Wisloff U, Kulseng B, Grimsmo J. Diastolic function and cardiovascular risk among patients with severe obesity referred to a lifestyle-program - a pilot study. Scand Cardiovasc J. 2023 Dec;57(1):8-16. doi: 10.1080/14017431.2022.2146185.

    PMID: 36404730DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Line Oldervoll, PhD

    LHL klinikkene / NTNU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 7, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 27, 2018

Record last verified: 2018-08

Locations

NO(1)