Weight-loss Treatment Through Smartphone-assisted Dietary Coaching

NCT02694614 | Completed DMC

• 1 other identifier: 17236.2 PFLS-LS
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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)

Conditions

Overweight; Obesity

Keywords

weight loss; individualised dietary coaching; smartphone-assisted dietary coaching; health behavior change

Outcome Measures

Primary Outcomes (1)

• Body weight change

  from baseline to week 52

Secondary Outcomes (14)

• Body weight change

  from baseline to week 12, week 104 (follow-up)

• BMI Change

  from baseline to week 12, week 52, week 104 (follow-up)

• Body fat

  from baseline to week 12, week 52, week 104 (follow-up)

• Waist circumference

  from baseline to week 12, week 52, week 104 (follow-up)

• HBA1c

  from baseline to week 12, week 52, week 104 (follow-up)

Other Outcomes (1)

• Contact frequency with dietician

  from baseline to week 12, week 52

Study Arms (1)

smartphone-assisted dietary coaching

EXPERIMENTAL

Behavioral: smartphone-assisted dietary coaching

Interventions

smartphone-assisted dietary coaching BEHAVIORAL

smartphone-assisted dietary coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oviva AG: lead
• Bern University of Applied Sciences: collaborator
• Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH: collaborator
• Swiss Commission for Technology and Innovation: collaborator

Study Sites (1)

Zentrum für Adipositas und Stoffwechselmedizin Winterthur GmbH

Winterthur, Canton of Zurich, 8400, Switzerland

Location

Related Publications (12)

• Donaldson EL, Fallows S, Morris M. A text message based weight management intervention for overweight adults. J Hum Nutr Diet. 2014 Apr;27 Suppl 2:90-7. doi: 10.1111/jhn.12096. Epub 2013 Jun 6.

  PMID: 23738786 BACKGROUND

• Aguilar-Martinez A, Sole-Sedeno JM, Mancebo-Moreno G, Medina FX, Carreras-Collado R, Saigi-Rubio F. Use of mobile phones as a tool for weight loss: a systematic review. J Telemed Telecare. 2014 Sep;20(6):339-49. doi: 10.1177/1357633X14537777. Epub 2014 May 29.

  PMID: 24875928 RESULT

• Appel LJ, Clark JM, Yeh HC, Wang NY, Coughlin JW, Daumit G, Miller ER 3rd, Dalcin A, Jerome GJ, Geller S, Noronha G, Pozefsky T, Charleston J, Reynolds JB, Durkin N, Rubin RR, Louis TA, Brancati FL. Comparative effectiveness of weight-loss interventions in clinical practice. N Engl J Med. 2011 Nov 24;365(21):1959-68. doi: 10.1056/NEJMoa1108660. Epub 2011 Nov 15.

  PMID: 22085317 RESULT

• Fukuoka Y, Kamitani E, Bonnet K, Lindgren T. Real-time social support through a mobile virtual community to improve healthy behavior in overweight and sedentary adults: a focus group analysis. J Med Internet Res. 2011 Jul 14;13(3):e49. doi: 10.2196/jmir.1770.

  PMID: 21752785 RESULT

• Hutchesson MJ, Rollo ME, Krukowski R, Ells L, Harvey J, Morgan PJ, Callister R, Plotnikoff R, Collins CE. eHealth interventions for the prevention and treatment of overweight and obesity in adults: a systematic review with meta-analysis. Obes Rev. 2015 May;16(5):376-92. doi: 10.1111/obr.12268. Epub 2015 Mar 5.

  PMID: 25753009 RESULT

• Levine DM, Savarimuthu S, Squires A, Nicholson J, Jay M. Technology-assisted weight loss interventions in primary care: a systematic review. J Gen Intern Med. 2015 Jan;30(1):107-17. doi: 10.1007/s11606-014-2987-6. Epub 2014 Aug 19.

  PMID: 25134692 RESULT

• Okorodudu DE, Bosworth HB, Corsino L. Innovative interventions to promote behavioral change in overweight or obese individuals: A review of the literature. Ann Med. 2015 May;47(3):179-85. doi: 10.3109/07853890.2014.931102. Epub 2014 Jul 10.

  PMID: 25011006 RESULT

• Radcliff TA, Bobroff LB, Lutes LD, Durning PE, Daniels MJ, Limacher MC, Janicke DM, Martin AD, Perri MG. Comparing Costs of Telephone vs Face-to-Face Extended-Care Programs for the Management of Obesity in Rural Settings. J Acad Nutr Diet. 2012 Sep;112(9):1363-1373. doi: 10.1016/j.jand.2012.05.002. Epub 2012 Jul 19.

  PMID: 22818246 RESULT

• Vodopivec-Jamsek V, de Jongh T, Gurol-Urganci I, Atun R, Car J. Mobile phone messaging for preventive health care. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD007457. doi: 10.1002/14651858.CD007457.pub2.

  PMID: 23235643 RESULT

• Siopis G, Chey T, Allman-Farinelli M. A systematic review and meta-analysis of interventions for weight management using text messaging. J Hum Nutr Diet. 2015 Feb;28 Suppl 2:1-15. doi: 10.1111/jhn.12207. Epub 2014 Jan 31.

  PMID: 24480032 RESULT

• Wing RR, Tate DF, Gorin AA, Raynor HA, Fava JL. A self-regulation program for maintenance of weight loss. N Engl J Med. 2006 Oct 12;355(15):1563-71. doi: 10.1056/NEJMoa061883.

  PMID: 17035649 RESULT

• Haas K, Hayoz S, Maurer-Wiesner S. Effectiveness and Feasibility of a Remote Lifestyle Intervention by Dietitians for Overweight and Obese Adults: Pilot Study. JMIR Mhealth Uhealth. 2019 Apr 11;7(4):e12289. doi: 10.2196/12289.

  PMID: 30973338 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Karin Haas, Dr.rer.nat.

  Bern University of Applied Sciences

  STUDY CHAIR

• Susanne Maurer-Wiesner, Dr.med.

  Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH

  PRINCIPAL INVESTIGATOR

• Kai Eberhardt, Dr.sci.ETH

  Oviva AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: February 29, 2016
• Study Start: March 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: June 1, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

CH (1)