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Trial record 2 of 4 for:    17035649 [PUBMED-IDS]

Weight-loss Treatment Through Smartphone-assisted Dietary Coaching (Oviva)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02694614
Recruitment Status : Completed
First Posted : February 29, 2016
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
Bern University of Applied Sciences
Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH
Swiss Commission for Technology and Innovation
Information provided by (Responsible Party):
Oviva AG

Brief Summary:

The purpose of this study is to evaluate the effectiveness and feasibility of weight loss counselling via a smartphone-app for patients with overweight/obesity in a 1-year long pilot study.

The study is organized in the following phases:

Recruitment (-14 to -2). Participants will be informed about the study. Participants agreed to enter the study and signed an informed consent.

Screening / Baseline measurement (week -2) Inclusion criteria will be checked. Anthropometric measurements: height, weight, waist circumference, body fat, blood pressure measurement, blood sampling for blood glucose; HbA1c, Insulin; Triglyceride, HDL-Cholesterol (assessment Part I). During the visit participants are requested to fill in a paper-pencil questionnaire: socioeconomic background (only at the beginning of the study), dietary and exercise habits, health-related quality of life, self-effectiveness (assessment part II). The participants are introduced to the smartphone assisted coaching.

Introductory phase (2 weeks): Participants take pictures of their meals with the app, which they send to the dietitian. After the introductory phase, the patients and the dietitians discuss via app how the patients should change their habits and agree on goals to reduce their weight.

Phase 1 (12 weeks): Intensive online counselling with the smartphone app, with the agreed upon goals in mind (5 days per week + one Skype call). Group counselling session with / without a dietitian are held if necessary. Furthermore, the dietitians make available information material for patient specific dietary topics online. Week 12: assessment I+II.

Phase 2 (until week 25): The habits that further a weight reduction are being stabilised - the frequency of the online counselling is reduced (3 days per week), group counselling with / without a dietitian are held if necessary. Furthermore, the dietitians hand out information material for patient specific dietary topics.

Phase 3 (week 26-52): This phase is relevant for maintaining the patient's wright. Online counselling happens once every 2 weeks. Group counselling with / without a dietitian are held if necessary. Furthermore, the dietitians hand out information material for patient specific dietary topics. At the end end, the dietitians will again collect data (assessment I+II). The online counselling process is evaluated with 3 group discussions.

Follow-up (week 104)


Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: smartphone-assisted dietary coaching Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weight-loss Treatment of Overweight / Obesity Patients Through Smartphone-assisted Dietary Coaching: A Pre-post Pilot Study
Study Start Date : March 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: smartphone-assisted dietary coaching Behavioral: smartphone-assisted dietary coaching



Primary Outcome Measures :
  1. Body weight change [ Time Frame: from baseline to week 52 ]

Secondary Outcome Measures :
  1. Body weight change [ Time Frame: from baseline to week 12, week 104 (follow-up) ]
  2. BMI Change [ Time Frame: from baseline to week 12, week 52, week 104 (follow-up) ]
  3. Body fat [ Time Frame: from baseline to week 12, week 52, week 104 (follow-up) ]
  4. Waist circumference [ Time Frame: from baseline to week 12, week 52, week 104 (follow-up) ]
  5. HBA1c [ Time Frame: from baseline to week 12, week 52, week 104 (follow-up) ]
  6. Fasting glucose [ Time Frame: from baseline to week 12, week 52, week 104 (follow-up) ]
  7. Fasting insulin [ Time Frame: from baseline to week 12, week 52, week 104 (follow-up) ]
  8. Triglyceride [ Time Frame: from baseline to week 12, week 52, week 104 (follow-up) ]
  9. HDL-cholesterol [ Time Frame: from baseline to week 12, week 52, week 104 (follow-up) ]
  10. Blood pressure [ Time Frame: from baseline to week 12, week 52, week 104 (follow-up) ]
  11. Physical Activity assessed using the Global physical activity Questionnaire (GPAQ) [ Time Frame: from baseline to week 12, week 52, week 104 (follow-up) ]
    To assess changes in physical activity, the investigators will use the Global physical activity Questionnaire (GPAQ)

  12. Eating behaviour assessed using a brief dietary assessment [ Time Frame: from baseline to week 12, week 52, week 104 (follow-up) ]
    To assess changes in eating behavior, the investigators will use a brief dietary assessment

  13. Overall health status assessed using the short version quality of life assessment tool (SF12) [ Time Frame: from baseline to week 12, week 52, week 104 (follow-up) ]
    To assess changes of the overall health status, the investigators will use the short version quality of life assessment tool (SF12)

  14. Self-efficacy assessed using a questionnaire [ Time Frame: from baseline to week 12, week 52, week 104 (follow-up) ]
    To assess the self-efficacy related to dietary change, the investigators will use a questionnaire from Hahn, Schwarzer, Renner (1996)


Other Outcome Measures:
  1. Contact frequency with dietician [ Time Frame: from baseline to week 12, week 52 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • Adults (18 years and over; BMI ≥ 27 kg/m2 and ≤ 32 kg/m2) with fluent German
  • Smartphone user (iOS or Android)
  • Capable of sending / receiving text messages and pictures

Exclusion Criteria:

  • Women who are pregnant or breast feeding
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
  • Persons who were on a diet during the last 6 months; take medication for weight loss at any time before, or are enrolled in another weight loss program
  • Persons with nutrition therapy dependent diseases and other serious diseases requiring continuous drug therapy
  • Enrolment of the investigator, his/her family members, employees and other dependent persons.
  • Individuals who will perform the interventions: registered dietitians

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694614


Locations
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Switzerland
Zentrum für Adipositas und Stoffwechselmedizin Winterthur GmbH
Winterthur, Zürich, Switzerland, 8400
Sponsors and Collaborators
Oviva AG
Bern University of Applied Sciences
Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH
Swiss Commission for Technology and Innovation
Investigators
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Study Chair: Karin Haas, Dr.rer.nat. Bern University of Applied Sciences
Principal Investigator: Susanne Maurer-Wiesner, Dr.med. Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH
Study Director: Kai Eberhardt, Dr.sci.ETH Oviva AG

Additional Information:
Publications of Results:

Other Publications:
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Responsible Party: Oviva AG
ClinicalTrials.gov Identifier: NCT02694614     History of Changes
Other Study ID Numbers: 17236.2 PFLS-LS
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Oviva AG:
weight loss
individualised dietary coaching
smartphone-assisted dietary coaching
health behavior change

Additional relevant MeSH terms:
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Obesity
Overweight
Weight Loss
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes