NCT04409197

Brief Summary

During confinement, food intake can become compulsive, physical activity is significantly reduced, sleep is altered with exacerbated anxiety and stress levels and increased family violence. In some at-risk patients, mental health may even deteriorate. The temptation is great for all to take refuge in food or in front of screens. The main elements that can impact weight changes during this period of confinement are stress and anxiety, lack of physical activity, changes in eating habits, sleep disturbance and alcohol consumption. The investigators wish to study the impact of confinement on pre-post confinement weight loss kinetics in adults included in weight reduction programs (RNPC).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,789

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2020

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

May 18, 2020

Last Update Submit

December 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Analyse the variation in weight loss kinetics before, during and after confinement in patients enrolled in a weight reduction programme (RNPC) in France

    3 months

Secondary Outcomes (4)

  • Define the effects of containment on the variation in the kinetics of anthropometric parameters other than weight

    3 months

  • Evolution of blood pressure before versus after confinement

    3 months

  • Characterize clusters (homogeneous groups of patients) associated with particular dynamics of weight kinetics during confinement

    3 months

  • Evaluate the impact of teleconsultation monitoring during containment on weight loss

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects will be recruited from patients enrolled in a Nutritional Psycho-Behavioural Re-education (RNPC) programme in one of the RNPC centres in France.

You may qualify if:

  • BMI \> 25 kg/m² and/or waist circumference \> 80 cm in women and 94 cm in men
  • Persons registered in the RNPC program
  • Be legally able to give consent after adequate information and submission of the information note
  • Person affiliated to social security

You may not qualify if:

  • Being unable to understand, follow objectives and methods due to cognition or language problems Subjects listed in articles L1121-5 à L1121-8: Pregnant women, feeding and parturient; subject under administrative or judicial control, persons who are protected under the act.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble Alpes

Grenoble, France

Location

Related Publications (1)

  • Bailly S, Fabre O, Legrand R, Pantagis L, Mendelson M, Terrail R, Tamisier R, Astrup A, Clement K, Pepin JL. The Impact of the COVID-19 Lockdown on Weight Loss and Body Composition in Subjects with Overweight and Obesity Participating in a Nationwide Weight-Loss Program: Impact of a Remote Consultation Follow-Up-The CO-RNPC Study. Nutrients. 2021 Jun 23;13(7):2152. doi: 10.3390/nu13072152.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Louis PEPIN

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2020

First Posted

June 1, 2020

Study Start

May 8, 2020

Primary Completion

June 8, 2020

Study Completion

July 11, 2020

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations