Direct Measurement of Food Intake Behaviour in Obese Women Before and After Bariatric Surgery or Lifestyle Intervention

NCT04990947 | Unknown DMC

• 1 other identifier: 2020-1594
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To assess changes in food intake and food preference (e.g., fat and sugar) after bariatric surgery and lifestyle intervention alone with a direct measurement.

Conditions

Bariatric Surgery Candidate; Lifestyle; Obesity

Outcome Measures

Primary Outcomes (1)

• Changes in caloric intake

  kcal consumed

  Before RYGB / lifestyle compared to 4 weeks, 3 months, 6 months and 12 months after RYGB / lifestyle

Secondary Outcomes (3)

• Weight / BMI

  baseline, 4weeks, 3 months, 6 months, 12 months

• Drinking microstructure over time

  baseline, 4weeks, 3 months, 6 months, 12 months

• Change in self-reported hunger, thirst, fullness, preference

  baseline, 4weeks, 3 months, 6 months, 12 months

Study Arms (2)

Bariatric surgery (Roux-en-Y Gastric Bypass)

Patients who are eligible for RYGB

Other: lifestyle / RYGB

Lifestyle group

Patients with a BMI \> 30 who will start a lifestyle program

Other: lifestyle / RYGB

Interventions

lifestyle / RYGB OTHER

No intervention, just 2 different groups will be included

Bariatric surgery (Roux-en-Y Gastric Bypass); Lifestyle group

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

RYGB or obesity with lifestyle intervention

You may qualify if:

• Woman
• Age between 18 and 67 years of age (standard for eligibility for bariatric surgery)
• Patients must be able to adhere to the study visit schedule
• Independently mobile
• Patients must be able to give informed consent (IC) prior to any study procedures
• Surgical (1) and non-surgical (2) groups:
• Eligible for bariatric surgery (BMI \> 35 kg/m2 and clinically indicated bariatric surgery operation in agreement with the IFSO criteria)
• Patients with a BMI of 30-40 kg/m2, who are planning to join the COOL-lifestyle program

You may not qualify if:

• Pre-operatively/lifestyle group: Factors impairing ability to consume meal such as: Significant dysphagia; Gastric outlet obstruction; Anything factor that prevents subjects from drinking or eating a meal
• Post-operatively: Factors impairing ability to consume meal such as: Significant and persistent surgical complications or anything that prevents subjects from drinking or eating a meal.
• Systemic or gastrointestinal condition which may affect food intake or preference (including diabetes mellitus)
• Pregnancy or lactation, or planning to get pregnant during the study period
• Patients who have an intolerance or allergy for one of the components of the test product (e.g. lactose)
• Active and significant psychiatric illness including substance misuse
• Significant cognitive or communication issues
• Medications with documented effect on food intake or food preference
• Participating in another scientific study at the same time, if

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Yonta van der Burgh

Arnhem, 6815 AD, Netherlands

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 5, 2021
• Study Start: April 7, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 5, 2021

Record last verified: 2021-02

Locations

NL (1)