Clinical trial NCT05997771: A Personal Nutrition Advisor to Assist Remote Dietary Counselling for Weight Loss and Maintenance
Official title: A Personal Nutrition Advisor to Assist Remote Dietary Counselling for Weight Loss and Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Nutritional counselling
Personalised nutrition
Dietary advice
Usability
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The evaluation of the usability will be done using a prospective single arm design (n=80). In addition, we will collect data regarding the efficacy of the intervention by comparing results of the study participants to results of historical controls (n=80). Historical controls are patients receiving the same usual care dietary counselling as the study participants but without assistance by the personal nutrition advisor.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to assess the usability of the PNA and satisfaction with the treatment within the framework of usual care remote nutritional counselling for GLP-1-supported weight management and collect pilot data on its potential to support weight loss.

Detailed description: The global prevalence of obesity and overweight is increasing and persistently drives global mortality and morbidity.As overweight and obesity are the result of an imbalance between energy intake and energy use, achieving a negative energy balance build the foundation for weight loss. Whilst dietary modification as a standalone procedure often fail in achieving or maintaining weight loss, the recent advent of supportive Glucagon-like Peptide-1 (GLP-1) based pharmacotherapies have greatly changed the landscape.Dietary counselling help people on GLP-1 based treatment reaching their individual weight goals and continued reimbursement of medication costs. However, nutritional advice provided by dietitians is often generic, not sufficiently aligned to individual weight loss trajectories.

The "Personal Nutrition Advisor" (PNA) is a decision support tool which is built upon an interpretable weight prediction model based on the energy balance equation (energy intake is a function of recorded dietary intake and a latent part dependent on observed weight changes, whereas energy expenditure is a function of weight and physical activity). Food, weight- and activity records captured using a smartphone application represent input data to the model. Output of the model is the predicted body weight trajectory alongside with personalized recommendations to reach a pre-defined target weight.

Integrating the PNA into a remote dietary counselling programme, in which certified dietitians deliver nutritional and lifestyle coaching via an application, has the potential to improve treatment satisfaction and efficacy. Therefore, the purpose of the study assess the usability of the PNA and satisfaction with the treatment within the framework of usual care remote nutritional counselling for GLP-1-supported weight management and collect pilot data on its potential to support weight loss.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Receiving GLP-1-based pharmacotherapy in combination with remote nutritional counselling
* Achieved weight loss of ≥5 (for baseline BMI 28-35 kg/m2) or ≥7% (for baseline BMI≥35kg/m2) after 4 months of GLP-1 based therapy (1st milestone)

Exclusion Criteria:

* Inability to give written informed consent
* Any physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
* Self-reported pregnancy, planed pregnancy within next 3 months or breast-feeding
* Concomitant participation in another trial that interferes with the normal conduct of the study and interpretation of the study results
* Not proficient in German

Primary outcomes:
measure: Change in the overall mean satisfaction score of the Nutritional and Dietetic Patient Outcomes Questionnaire (NDPOQ)
timeFrame: From baseline to 3 months of the respective study period
measure: The overall mean score of the "perceived impact" section from the user version of the mobile application scale (uMARS )
timeFrame: Post intervention visit (3 months after baseline)
measure: The overall mean score of the Healthcare Systems Usability Scale (HSUS)
timeFrame: Post intervention visit (3 months after baseline)
Secondary outcomes:
measure: Change in self reported weight (%)
timeFrame: From baseline to 3 months of the respective study period
measure: Proportion of patients reaching >5% weight loss
timeFrame: At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period
measure: Proportion of patients reaching >10% weight loss
timeFrame: At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period
measure: Proportion of patients reaching >15% weight loss
timeFrame: At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period
measure: Change in daily number of logged meals and beverages
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Change in energy intake (kcal/day)
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Change in energy expenditure (kcal/day)
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Change in relative carbohydrate content (%)
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Change in relative protein content (%)
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Change in relative fat content (%)
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Change in relative fiber content (%)
timeFrame: From the first day of the respective study period to 3 months thereafter
measure: Change in self-reported exercise engagement per week (hours/week)
timeFrame: At baseline and at 3 months of study intervention
measure: Change in the overall mean score of the General Self-efficacy Scale (GSE) from Imperial College London
timeFrame: From baseline to 3 months of the respective study period
measure: Collection of open ended PNA specific feedback questionnaires
timeFrame: Post intervention visit (3 months after baseline)
measure: Qualitative collection of patient reported PNA specific feedback.
timeFrame: Post intervention visit (3 months after baseline)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Study officials:
affiliation: Inselspital University Hospital Bern, University of Bern
name: Lia Bally, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: