Weight-loss Treatment of Overweight / Obesity Patients Through Smartphone-assisted Dietary Coaching: A Pre-post Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Body weight change
Study Overview
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)
Detailed Description
Recruitment process will be conducted in two parts. During the first part potential participants will be recruited:
- At the obesity centre during the current obesity consultation
- During regularly information events at the obesity centre flyers will be handed out.
- During training courses for general practitioner at the obesity centre flyers will be handed out.
- Through the network Medical AdiNetwork flyers will be send to general practitioner.
- Advertisement: via website Oviva, Berne University of Applied Science, Zentrum für Adipositas- und Stoffwechselmedizin Winterthur (ZAS) GmbH; Newspaper "Winterthur Stadt Anzeiger".
Participants receive written and verbal information about the study. After participants have given informed consent for participation the second phase (screening process) take place. The researchers determine eligibility of participants based on the inclusion and exclusion criteria at the Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH.
Description of variables:
Weight: Measurement take place in the morning, using a clinically validated and calibrated scale (Seca mBCA 515, medical Body Composition Analyzer). The participant should be clothed lightly, without shoes. Weight is recorded within 0.01 kg.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
smartphone-assisted dietary coaching
Intervention: smartphone-assisted dietary coaching (Behavioral)
Outcomes
Primary Outcomes
Body weight change
Time Frame: from baseline to week 52
Secondary Outcomes
- 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))
- Fasting glucose(from baseline to week 12, week 52, week 104 (follow-up))
- Blood pressure(from baseline to week 12, week 52, week 104 (follow-up))
- Waist circumference(from baseline to week 12, week 52, week 104 (follow-up))
- Body weight change(from baseline to week 12, week 104 (follow-up))
- Fasting insulin(from baseline to week 12, week 52, week 104 (follow-up))
- Triglyceride(from baseline to week 12, week 52, week 104 (follow-up))
- Self-efficacy assessed using a questionnaire(from baseline to week 12, week 52, week 104 (follow-up))
- HBA1c(from baseline to week 12, week 52, week 104 (follow-up))
- HDL-cholesterol(from baseline to week 12, week 52, week 104 (follow-up))
- Physical Activity assessed using the Global physical activity Questionnaire (GPAQ)(from baseline to week 12, week 52, week 104 (follow-up))
- Eating behaviour assessed using a brief dietary assessment(from baseline to week 12, week 52, week 104 (follow-up))
- Overall health status assessed using the short version quality of life assessment tool (SF12)(from baseline to week 12, week 52, week 104 (follow-up))