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

NCT05997771 | Completed

• 1 other identifier: PNA-ORIGINATE
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Nutritional counselling; Personalised nutrition; Dietary advice; Usability

Outcome Measures

Primary Outcomes (3)

• Change in the overall mean satisfaction score of the Nutritional and Dietetic Patient Outcomes Questionnaire (NDPOQ)

  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 )

  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)

  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 Outcomes (15)

• Change in self reported weight (%)

  From baseline to 3 months of the respective study period

• Proportion of patients reaching >5% weight loss

  At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period

• Proportion of patients reaching >10% weight loss

  At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period

• Proportion of patients reaching >15% weight loss

  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

  From the first day of the respective study period to 3 months thereafter

Study Arms (1)

Study Intervention Group

EXPERIMENTAL

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

Interventions

Personal Nutrition Advisor 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.

Study Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lia Bally: lead

Study Sites (1)

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

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Lia Bally, MD-PhD

  Inselspital University Hospital Bern, University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.med. et Dr. phil.

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: August 18, 2023
• Study Start: August 25, 2023
• Primary Completion: April 22, 2024
• Study Completion: May 6, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of the study results in a peer-reviewed journal
• Access Criteria: Contact with an approval by the corresponding author

Locations

CH (1)