A Personal Nutrition Advisor to Assist Remote Dietary Counselling for Weight Loss and Maintenance

NCT ID: NCT05997771

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-25
• Study Completion Date: 2024-05-06

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.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Study Intervention Group

The study intervention group will be undergoing 3 months of Personalized Nutrition Advisor (PNA)-assisted remote nutritional counselling.The PNA data analysis tool will be used by the dietitians during remote nutritional counselling sessions.The service will be delivered to patients undergoing GLP-1 based obesity treatment as part of their usual care. The study intervention group will report treatment-satisfaction and self-efficacy via questionnaires at baseline, 1.5 - and 3 months.

Patients who expressed their interest in participating in a focus group at the time of study inclusion, will be invited for a 60 min online interview session chaired by an experienced moderator. The focus group will consists of a maximum of 10 participants and address the patient's perspective on the utility of the dietitians' advice, discrepancy from expectations, general feedback and suggestions for PNA improvement using a semi structured discussion guide held in an open and spontaneous format

Group Type: EXPERIMENTAL

Personal Nutrition Advisor

Intervention Type: OTHER

The study intervention will be the use of the PNA data analysis tool during remote nutritional counselling sessions delivered by certified dietitians, also referred to as PNA-assisted remote nutritional counselling.

Interventions

Personal Nutrition Advisor

The study intervention will be the use of the PNA data analysis tool during remote nutritional counselling sessions delivered by certified dietitians, also referred to as PNA-assisted remote nutritional counselling.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lia Bally

OTHER

Sponsor Role: lead

Responsible Party

Lia Bally

Prof. Dr.med. et Dr. phil.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lia Bally, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Inselspital University Hospital Bern, University of Bern

Locations

Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

PNA-ORIGINATE

Identifier Type: -

Identifier Source: org_study_id