General practitioner-centered rural obesity management: Design, protocol and baseline data of the German HAPpEN pragmatic trial

Objective: HAPpEN aims to implement and evaluate a holistic general practitioner-centered, interdisciplinary obesity management strategy in rural Germany, focusing on feasibility, health outcomes, and economic benefits. Methods: HAPpEN is a 12-month, pragmatic single-arm, multicenter trial, informed...

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Main Authors: Marika Haderer, Reiner Hofmann, Tina Bartelmeß, Laura König, Constanze Betz, Mirna Al Masri, Alisa Bader, Natascha von Schau
Format: Article
Language:English
Published: Elsevier 2025-01-01
Series:Preventive Medicine Reports
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Online Access:http://www.sciencedirect.com/science/article/pii/S2211335524003747
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author Marika Haderer
Reiner Hofmann
Tina Bartelmeß
Laura König
Constanze Betz
Mirna Al Masri
Alisa Bader
Natascha von Schau
author_facet Marika Haderer
Reiner Hofmann
Tina Bartelmeß
Laura König
Constanze Betz
Mirna Al Masri
Alisa Bader
Natascha von Schau
author_sort Marika Haderer
collection DOAJ
description Objective: HAPpEN aims to implement and evaluate a holistic general practitioner-centered, interdisciplinary obesity management strategy in rural Germany, focusing on feasibility, health outcomes, and economic benefits. Methods: HAPpEN is a 12-month, pragmatic single-arm, multicenter trial, informed by a formative survey, and initiated in April 2023 with 98 obese participants (body mass index, BMI ≥ 30 kg/m2) in Kulmbach, Germany. The program integrates nutritional counseling, physical activity, and behavior change techniques, including smartphone-based self-monitoring. Monthly consultations help set personalized goals using a multi-stage grading scale. Primary outcomes include BMI, body weight, waist circumference, heart rate, blood pressure and parameters, while secondary outcomes assess quality of life, wellbeing, health literacy, social interaction, and digital therapy support. Results: The baseline cohort (mean age: 46.9 ± 11.8 years, 74.1 % female) exhibited high obesity rates (mean BMI: 40.1 ± 6.1 kg/m2), with 48.5 % classified as grade III obese. Common comorbidities were hypertension (51.8 %), dyslipidemia (30.5 %) and diabetes (21.8 %). Chronic joint paint, mainly in the knees and hips, affected up to 82.4 %. A familial aggregation of obesity, diabetes, and cardiovascular diseases was noted, alongside behavioral challenges such as lack of physical activity (81.8 %) and unhealthy eating habits (56.8 %). Conclusion: HAPpEN addresses obesity's multifactorial nature through general practitioner-led, community-based, and digital strategies to promote sustainable lifestyle changes in rural areas. The trial aims to inform primary care obesity management guidelines, focusing on improving health literacy, patient engagement, and long-term clinical benefits. German Clinical Trials Register: DRKS00033916.
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spelling doaj-art-f69eec711bcf45178dad4e0d1c8b925c2025-01-11T06:41:18ZengElsevierPreventive Medicine Reports2211-33552025-01-0149102959General practitioner-centered rural obesity management: Design, protocol and baseline data of the German HAPpEN pragmatic trialMarika Haderer0Reiner Hofmann1Tina Bartelmeß2Laura König3Constanze Betz4Mirna Al Masri5Alisa Bader6Natascha von Schau7Institute for Medical Management and Health Sciences, Project office of the Medical Campus Upper Franconia, University of Bayreuth, Bayreuth, Germany; Corresponding author at: Institute for Medical Management and Health Sciences, Project office of the Medical Campus Upper Franconia, University of Bayreuth, Prieserstraße 2, 95444 Bayreuth, Germany.Institute for Medical Management and Health Sciences, Project office of the Medical Campus Upper Franconia, University of Bayreuth, Bayreuth, GermanyFaculty of Life Sciences: Food, Nutrition, and Health, University of Bayreuth, Kulmbach, GermanyFaculty of Life Sciences: Food, Nutrition, and Health, University of Bayreuth, Kulmbach, Germany; Faculty of Psychology, University of Vienna, Vienna, AustriaFaculty of Life Sciences: Food, Nutrition, and Health, University of Bayreuth, Kulmbach, GermanyFaculty of Life Sciences: Food, Nutrition, and Health, University of Bayreuth, Kulmbach, GermanyInstitute for Medical Management and Health Sciences, Project office of the Medical Campus Upper Franconia, University of Bayreuth, Bayreuth, GermanyInstitute of General Practice, Friedrich-Alexander University Erlangen, Nuernberg, GermanyObjective: HAPpEN aims to implement and evaluate a holistic general practitioner-centered, interdisciplinary obesity management strategy in rural Germany, focusing on feasibility, health outcomes, and economic benefits. Methods: HAPpEN is a 12-month, pragmatic single-arm, multicenter trial, informed by a formative survey, and initiated in April 2023 with 98 obese participants (body mass index, BMI ≥ 30 kg/m2) in Kulmbach, Germany. The program integrates nutritional counseling, physical activity, and behavior change techniques, including smartphone-based self-monitoring. Monthly consultations help set personalized goals using a multi-stage grading scale. Primary outcomes include BMI, body weight, waist circumference, heart rate, blood pressure and parameters, while secondary outcomes assess quality of life, wellbeing, health literacy, social interaction, and digital therapy support. Results: The baseline cohort (mean age: 46.9 ± 11.8 years, 74.1 % female) exhibited high obesity rates (mean BMI: 40.1 ± 6.1 kg/m2), with 48.5 % classified as grade III obese. Common comorbidities were hypertension (51.8 %), dyslipidemia (30.5 %) and diabetes (21.8 %). Chronic joint paint, mainly in the knees and hips, affected up to 82.4 %. A familial aggregation of obesity, diabetes, and cardiovascular diseases was noted, alongside behavioral challenges such as lack of physical activity (81.8 %) and unhealthy eating habits (56.8 %). Conclusion: HAPpEN addresses obesity's multifactorial nature through general practitioner-led, community-based, and digital strategies to promote sustainable lifestyle changes in rural areas. The trial aims to inform primary care obesity management guidelines, focusing on improving health literacy, patient engagement, and long-term clinical benefits. German Clinical Trials Register: DRKS00033916.http://www.sciencedirect.com/science/article/pii/S2211335524003747ObesityPrimary health careeHealthPragmatic trialSocial supportRural
spellingShingle Marika Haderer
Reiner Hofmann
Tina Bartelmeß
Laura König
Constanze Betz
Mirna Al Masri
Alisa Bader
Natascha von Schau
General practitioner-centered rural obesity management: Design, protocol and baseline data of the German HAPpEN pragmatic trial
Preventive Medicine Reports
Obesity
Primary health care
eHealth
Pragmatic trial
Social support
Rural
title General practitioner-centered rural obesity management: Design, protocol and baseline data of the German HAPpEN pragmatic trial
title_full General practitioner-centered rural obesity management: Design, protocol and baseline data of the German HAPpEN pragmatic trial
title_fullStr General practitioner-centered rural obesity management: Design, protocol and baseline data of the German HAPpEN pragmatic trial
title_full_unstemmed General practitioner-centered rural obesity management: Design, protocol and baseline data of the German HAPpEN pragmatic trial
title_short General practitioner-centered rural obesity management: Design, protocol and baseline data of the German HAPpEN pragmatic trial
title_sort general practitioner centered rural obesity management design protocol and baseline data of the german happen pragmatic trial
topic Obesity
Primary health care
eHealth
Pragmatic trial
Social support
Rural
url http://www.sciencedirect.com/science/article/pii/S2211335524003747
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