Better App: (Further-)Development and Evaluation of a Digital Lifestyle Programme

NCT05837468 | Unknown

• 1 other identifier: METCZ20230037
• Study Type: observational
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief Summary

In recent years, we developed and evaluated personalised lifestyle interventions, the BETTER programmes (BETER in Dutch, acronym for Move, Eat, Change). Underlying principle for all BETER programmes is that people with the same condition may have different underlying causes, so-called subtypes. In this follow-up project with a mixed methods design, we aim to evaluate and optimise the subtype-questionnaire/algorithm (study 1, interrater reliabiliy) and evaluate the digitised BETER programme, the BETTER App (study 2, case series design with qualitative and quantitative evaluation). The main questions it aims to answer are:

1. 1.What is the inter-rater reliability of two subtype experts and criterion validity of the symptom questionnaire compared with the experts for identifying overweight subtypes?
2. 2.How is the BETER app used and rated (process evaluation)? To answer question 1, participants complete a questionnaire and have two interviews with two experts. To answer question 2, participants use the BETTERapp for 6 weeks and complete a usability questionnaire after 3 and 6 weeks and participate in 1 or 2 focus group interviews. This study contributes to optimising the Minimal Viable Product of the BETER app to finally reach a mature version.

Conditions

Healthy Lifestyle; Health Behavior

Keywords

Lifestyle; Behavior Change; Digital Lifestyle Application; Overweight; Subtypes

Outcome Measures

Primary Outcomes (4)

• inter-rater reliability

  To assess inter-rater reliability between the two experts, the Cohen's kappa (k) with standard error and percentage agreement is calculated between the two experts. A 95% confidence interval is used. Both the unweighted Kappa and the linearly weighted Kappa are calculated. By means of the weighted kappa, in case of difference, it can be examined whether this difference mainly occurs between certain subtypes and can be corrected for this

  from May to December 2023

• criterion validity

  For determining criterion validity, the degree of agreement is expressed as a correlation coefficient (r ≥ 0.8 is assessed as 'good' and used as a cut-off point). In addition, sensitivity, specificity and F1 score are assessed using a 5x5 table and the five "One versus Rest" ROC curves

  from May to December 2023

• Usability

  At T1 and T2, usage, experiences and ratings are mapped through a questionnaire (mHealth App Usability Questionnaire (MAUQ)) and focus group interviews

  from May to December 2023

• Use

  Log files automatically record how often a person logs in, which parts of the BETER app are used by participants and the duration of app use.

  from May to December 2023

Interventions

BETTERapp BEHAVIORAL

The BETTER app offers a 'tailor-made' lifestyle programme including the option of personal coaching for a duration of 6 weeks. The BETTER app is an automated and digitised lifestyle programme based on the previously developed and evaluated BETTER programme.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persons aged 16 years or older who are overweight or obese (body mass index (BMI) of 25 or higher). N = 50 (sub-study 1); N= 15 (substudy 2)

You may qualify if:

• Persons aged 16 years or older who are overweight or obese (body mass index (BMI) of 25 or higher)

Sponsors & Collaborators

• Zuyd University of Applied Sciences: lead

Related Publications (5)

• Hassan Y, Head V, Jacob D, Bachmann MO, Diu S, Ford J. Lifestyle interventions for weight loss in adults with severe obesity: a systematic review. Clin Obes. 2016 Dec;6(6):395-403. doi: 10.1111/cob.12161. Epub 2016 Oct 27.

  PMID: 27788558 BACKGROUND

• Burgess E, Hassmen P, Pumpa KL. Determinants of adherence to lifestyle intervention in adults with obesity: a systematic review. Clin Obes. 2017 Jun;7(3):123-135. doi: 10.1111/cob.12183. Epub 2017 Mar 15.

  PMID: 28296261 BACKGROUND

• Gillies CL, Abrams KR, Lambert PC, Cooper NJ, Sutton AJ, Hsu RT, Khunti K. Pharmacological and lifestyle interventions to prevent or delay type 2 diabetes in people with impaired glucose tolerance: systematic review and meta-analysis. BMJ. 2007 Feb 10;334(7588):299. doi: 10.1136/bmj.39063.689375.55. Epub 2007 Jan 19.

  PMID: 17237299 BACKGROUND

• van der Valk ES, van den Akker ELT, Savas M, Kleinendorst L, Visser JA, Van Haelst MM, Sharma AM, van Rossum EFC. A comprehensive diagnostic approach to detect underlying causes of obesity in adults. Obes Rev. 2019 Jun;20(6):795-804. doi: 10.1111/obr.12836. Epub 2019 Mar 1.

  PMID: 30821060 BACKGROUND

• Trouwborst I, Gijbels A, Jardon KM, Siebelink E, Hul GB, Wanders L, Erdos B, Peter S, Singh-Povel CM, de Vogel-van den Bosch J, Adriaens ME, Arts ICW, Thijssen DHJ, Feskens EJM, Goossens GH, Afman LA, Blaak EE. Cardiometabolic health improvements upon dietary intervention are driven by tissue-specific insulin resistance phenotype: A precision nutrition trial. Cell Metab. 2023 Jan 3;35(1):71-83.e5. doi: 10.1016/j.cmet.2022.12.002.

  PMID: 36599304 BACKGROUND

Related Links

• Kanera IM, Kleynen M, Schroën Y, de Jong van Luxemburg TJJ, Braun SM. Appreciation of the personalized BETER lifestyle intervention for overweight: a case series design

MeSH Terms

Conditions

Health Behavior; Overweight

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 1, 2023
• Study Start: May 11, 2023
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share