A Personal Nutrition Advisor to Assist Remote Dietary Counselling for Weight Loss and Maintenance (PNA-ORIGINATE)

June 3, 2024 updated by: Lia Bally
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the overall mean satisfaction score of the Nutritional and Dietetic Patient Outcomes Questionnaire (NDPOQ)
Time Frame: From baseline to 3 months of the respective study period
This outcome will evaluate the patient treatment satisfaction with the counselling of the "Personal Nutrition Advisor" (PNA) -assisted remote nutritional counselling. The NDPOQ includes a 5 point likert scale of agreement (5 points=strongly agree, 1 point= strongly disagree) of 15 questions.
From baseline to 3 months of the respective study period
The overall mean score of the "perceived impact" section from the user version of the mobile application scale (uMARS )
Time Frame: Post intervention visit (3 months after baseline)
This outcome will evaluate patient satisfaction with the counselling of the "Personal Nutrition Advisor" (PNA) -assisted remote nutritional counselling. The uMARS includes a 5 point likert scale of agreement (5 points=strongly agree, 1 point= strongly disagree) of 5 questions.
Post intervention visit (3 months after baseline)
The overall mean score of the Healthcare Systems Usability Scale (HSUS)
Time Frame: Post intervention visit (3 months after baseline)
This outcome will evaluate dietitian reported usability of the "Personal Nutrition Advisor" (PNA)- assisted remote nutritional counselling. HSUS includes a 5 point likert scale of agreement (5 points=strongly agree, 1 point= strongly disagree) of 20 questions.
Post intervention visit (3 months after baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self reported weight (%)
Time Frame: From baseline to 3 months of the respective study period
This outcome will evaluate the potential to support weight loss by PNA-assisted remote nutritional counselling (self-reported weight closest to start and end of the study period).
From baseline to 3 months of the respective study period
Proportion of patients reaching >5% weight loss
Time Frame: At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period
This outcome will evaluate the potential to support weight loss by PNA-assisted remote nutritional counselling (calculated from the initial weight, measured in-clinic at start of the GLP-1 based pharmacotherapy)
At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period
Proportion of patients reaching >10% weight loss
Time Frame: At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period
This outcome will evaluate the potential to support weight loss by PNA-assisted remote nutritional counselling (calculated from the initial weight, measured in-clinic at start of the GLP-1 based pharmacotherapy)
At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period
Proportion of patients reaching >15% weight loss
Time Frame: At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period
This outcome will evaluate the potential to support weight loss by PNA-assisted remote nutritional counselling (calculated from the initial weight, measured in-clinic at start of the GLP-1 based pharmacotherapy)
At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period
Change in daily number of logged meals and beverages
Time Frame: From the first day of the respective study period to 3 months thereafter
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on frequency of dietary self-monitoring (manual entries of pictures, text tags and food/beverage tags per day)
From the first day of the respective study period to 3 months thereafter
Change in energy intake (kcal/day)
Time Frame: From the first day of the respective study period to 3 months thereafter
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived dietary intake, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs.
From the first day of the respective study period to 3 months thereafter
Change in energy expenditure (kcal/day)
Time Frame: From the first day of the respective study period to 3 months thereafter
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived dietary expenditure, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs.
From the first day of the respective study period to 3 months thereafter
Change in relative carbohydrate content (%)
Time Frame: From the first day of the respective study period to 3 months thereafter
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived nutrient distribution, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs.
From the first day of the respective study period to 3 months thereafter
Change in relative protein content (%)
Time Frame: From the first day of the respective study period to 3 months thereafter
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived nutrient distribution, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs.
From the first day of the respective study period to 3 months thereafter
Change in relative fat content (%)
Time Frame: From the first day of the respective study period to 3 months thereafter
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived nutrient distribution, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs.
From the first day of the respective study period to 3 months thereafter
Change in relative fiber content (%)
Time Frame: From the first day of the respective study period to 3 months thereafter
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on PNA derived nutrient distribution, calculated by the energy balance model embedded in the PNA using manual entries of weight logs, meal logs and activity logs.
From the first day of the respective study period to 3 months thereafter
Change in self-reported exercise engagement per week (hours/week)
Time Frame: At baseline and at 3 months of study intervention
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on self-reported physical activity using manual entries of activity logs.
At baseline and at 3 months of study intervention
Change in the overall mean score of the General Self-efficacy Scale (GSE) from Imperial College London
Time Frame: From baseline to 3 months of the respective study period
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on self-efficacy. GSE includes a 5 point Likert scale of confidence (Not at all confident =1 point, Extremely confident=5 points) of 6 questions.
From baseline to 3 months of the respective study period
Collection of open ended PNA specific feedback questionnaires
Time Frame: Post intervention visit (3 months after baseline)
This qualitative outcome will collect opinions from patients and dietitians regarding the components of the PNA with the aim to further optimise its perceived usefulness.
Post intervention visit (3 months after baseline)
Qualitative collection of patient reported PNA specific feedback.
Time Frame: Post intervention visit (3 months after baseline)
This qualitative outcome will be assessed by an semi structured remote patient group interview addressing the patient's perspective on the utility of the dietitians' advice, discrepancy from expectations, general feedback and suggestions for PNA improvement.
Post intervention visit (3 months after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lia Bally

Investigators

  • Principal Investigator: Lia Bally, MD-PhD, Inselspital University Hospital Bern, University of Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2023

Primary Completion (Actual)

April 22, 2024

Study Completion (Actual)

May 6, 2024

Study Registration Dates

First Submitted

June 15, 2023

First Submitted That Met QC Criteria

August 11, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNA-ORIGINATE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised individual participant data will be shared after inquiry via a validated sharing platform (yet to be defined). Anonymised data packages will be available once the final study results are published in a peer-reviewed journal.

IPD Sharing Time Frame

After publication of the study results in a peer-reviewed journal

IPD Sharing Access Criteria

Contact with an approval by the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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