ObesityPNA-ORIGINATENCT05997771
A Personal Nutrition Advisor to Assist Remote Dietary Counselling for Weight Loss and Maintenance
A study testing Personal Nutrition Advisor in people with Obesity, run by Lia Bally at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Personal Nutrition Advisor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Aug 2023to 6 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Bern, 3010
About this study
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.
Read the 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
- Being tested
- Personal Nutrition Advisor
- Keywords
- Nutritional counselling, Personalised nutrition, Dietary advice, Usability
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal Nutrition AdvisorOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Personal Nutrition Advisor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Post intervention visit (3 months after baseline)
Secondary outcomes (15)
Change in self reported weight (%)
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).
Measured: From baseline to 3 months of the respective study period
Proportion of patients reaching >5% weight loss
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)
Measured: At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period
Proportion of patients reaching >10% weight loss
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)
Measured: At start of the GLP-1 based pharmacotherapy to 3 months of the respective study period
Proportion of patients reaching >15% weight loss
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)
Measured: 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
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)
Measured: From the first day of the respective study period to 3 months thereafter
Change in energy intake (kcal/day)
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.
Measured: From the first day of the respective study period to 3 months thereafter
Change in energy expenditure (kcal/day)
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.
Measured: From the first day of the respective study period to 3 months thereafter
Change in relative carbohydrate content (%)
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.
Measured: From the first day of the respective study period to 3 months thereafter
Change in relative protein content (%)
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.
Measured: From the first day of the respective study period to 3 months thereafter
Change in relative fat content (%)
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.
Measured: From the first day of the respective study period to 3 months thereafter
Change in relative fiber content (%)
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.
Measured: From the first day of the respective study period to 3 months thereafter
Change in self-reported exercise engagement per week (hours/week)
This outcome will evaluate the impact of PNA-assisted remote nutritional counselling on self-reported physical activity using manual entries of activity logs.
Measured: 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
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.
Measured: From baseline to 3 months of the respective study period
Collection of open ended PNA specific feedback questionnaires
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.
Measured: Post intervention visit (3 months after baseline)
Qualitative collection of patient reported PNA specific feedback.
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.
Measured: Post intervention visit (3 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start25 Aug 2023
- Primary completion22 Apr 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lia Bally
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lia Bally, Insel Gruppe AG, University Hospital Bern
- Investigators
- Lia Bally, MD-PhD, Principal investigator, Inselspital University Hospital Bern, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997771
- Sponsor's protocol ID
- PNA-ORIGINATE
- Acronym
- PNA-ORIGINATE
- Status last verified
- Jun 2024
- First submitted
- 15 Jun 2023
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Orban F, Journeaux A, Kanehl P, Stoll M, Lehmann M, Schirmann F, Herzig D, Bally L. Clinical Decision Support for Digital Dietary Counseling Under GLP-1 Receptor Agonist Therapy: Convergent Mixed Methods Usability and Treatment Satisfaction Pilot Study of the Personalized Nutrition Advisor. JMIR Form Res. 2026 Jul 21;10:e81112. doi: 10.2196/81112.
PubMed 42522425
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personal Nutrition Advisor to Assist Remote Dietary Counselling for Weight Loss and Maintenance
- ClinicalTrials.gov ID
- NCT05997771
- Acronym / sponsor ID
- PNA-ORIGINATE / PNA-ORIGINATE
- Conditions
- Obesity
- Keywords
- Nutritional counselling, Personalised nutrition, Dietary advice, Usability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Lia BallyUniversity, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Intervention Group | Experimental | Other: Personal Nutrition AdvisorThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal Nutrition AdvisorThe 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. | Other | Study Intervention Group |
Primary outcome
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.
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.
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.
15 secondary outcomes
Change in self reported weight (%)
Time frame: 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
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
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
Change in daily number of logged meals and beverages
Time frame: 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
Change in energy expenditure (kcal/day)
Time frame: 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
Change in relative protein content (%)
Time frame: 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
Change in relative fiber content (%)
Time frame: 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
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
Collection of open ended PNA specific feedback questionnaires
Time frame: Post intervention visit (3 months after baseline)
Qualitative collection of patient reported PNA specific feedback.
Time frame: Post intervention visit (3 months after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 42522425Orban F, Journeaux A, Kanehl P, Stoll M, Lehmann M, Schirmann F, Herzig D, Bally L. Clinical Decision Support for Digital Dietary Counseling Under GLP-1 Receptor Agonist Therapy: Convergent Mixed Methods Usability and Treatment Satisfaction Pilot Study of the Personalized Nutrition Advisor. JMIR Form Res. 2026 Jul 21;10:e81112. doi: 10.2196/81112.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lia Bally, MD-PhD principal investigator
Inselspital University Hospital Bern, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal Nutrition Advisor in people with Obesity, run by Lia Bally at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05997771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.