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NCT Number: NCT05997771

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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).

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Sponsors and collaborators

Lead sponsor

Lia Bally

Other

Registry information

Acronym: PNA-ORIGINATE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2023
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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