NCT02431195

Brief Summary

The main objective of this study is to identify changes in eating behaviors and physical activity in patients after bariatric surgery and their family members living in same household: children aged between 11-17 years, spouse, parents, cohabitee or partner in a civil union.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

3.9 years

First QC Date

March 17, 2015

Last Update Submit

June 18, 2019

Conditions

Keywords

obesitybariatric surgeryphysical activityeating habits

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline in different eating habits and culinary items in responses to questionnaires

    Changes from baseline in different eating habits and culinary items in responses to questionnaires at 3 months, 6 months and 1 year after bariatric surgery. It is expected that patient's feeding practice should be in accordance with the postsurgical dietary guidelines.

    At 3 month, 6 month and 12 month

Secondary Outcomes (2)

  • Changes from baseline in different items about physical activity in responses to questionnaires

    At 3 month, 6 month and 12 month

  • Quality of life measured by scores

    At baseline, 3 month, 6 month and 12 month

Eligibility Criteria

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

Patients who will undergo bariatric surgery (bypass or sleeve) and live together with their families.

You may qualify if:

  • Aged ≥ 18 years
  • Eligible to undergo bariatric surgery
  • Post bariatric surgery follow-up visits will take place in the nutrition department
  • Living together with family member (children aged 11-17 years, parents, spouse, cohabitee or partner in civil union)
  • Informed consent signed

You may not qualify if:

  • Higher-order cognitive disorders
  • Language difficulties in understanding
  • Living alone or living without any family member

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition, CHU Ambroise Paré

Boulogne-Billancourt, Hauts Des Seine, 92100, France

Location

MeSH Terms

Conditions

ObesityMotor ActivityFeeding Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBehavior, Animal

Study Officials

  • Sébastien Czernichow, MD, PhD

    CHU Ambroise Paré

    PRINCIPAL INVESTIGATOR
  • Kàtia Lurbe-Puerto, PhD

    CHU Ambroise Paré

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 17, 2015

First Posted

April 30, 2015

Study Start

March 1, 2015

Primary Completion

February 1, 2019

Study Completion

June 1, 2019

Last Updated

June 19, 2019

Record last verified: 2019-06

Locations