UnknownNot Applicable

Weight Loss in Adults With Obesity Using a Combination of Low Energy Diet, Group Treatment and Intragastric Balloon

Sweden110 participantsStarted 2019-12-10

Plain-language summary

In Sweden, approximately 1.3 million adults have obesity. Obesity decreases quality of life (QoL) and increases the risk of diseases such as type 2-diabetes, non-alcoholic fatty liver disease (NAFLD), cancer and cardiovascular diseases. Consequently, weight loss improves QoL and decreases the risk for obesity-related comorbidities. A treatment combination using a low energy diet (LED) and group treatment based on cognitive behavioral therapy (CBT), leads to 18 percent weight loss after 6 months. Six months treatment with an intragastric balloon (IGB) leads to 13 percent weight loss. However, both treatments are usually followed by weight regain. Combining these treatments has not been studied before but could lead to better weight maintenance. The hypothesis is that treatment of adults with obesity, with LED, CBT and IGB, leads to greater weight loss after 1 year compared to treatment with LED and CBT only. The study is a randomized, controlled clinical trial, with a 2-year follow-up. One hundred and ten adults, age 30-65 years, with a BMI of 30-45 kg/m\^2 will be included. All participants will receive 6 months of LED, followed by randomization to either 6 months with IGB or a control group without IGB. All participants receive CBT-based group treatment during 12 months and followed up after 2 years. If the treatment combination of LED, CBT and IGB leads to significant weight loss and improved weight maintenance, increased QoL and reductions of comorbidities and costs of health care are expected. Effects of treatment on eating behavior, NAFLD, physical activity, psychological parameters, the gut microbiota, gut permeability and metabolomics will be assessed.

Who can participate

Age range

30 Years – 65 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * BMI ≥ 30 and ≤45 kg/m\^2 * Age 30 to 65 years Exclusion Criteria: * Participation in an organized weight reduction programme or pharmacological treatment for weight loss within the last 3 months * Daily use of meal replacement products within the last 3 months * Previous gastric surgery * Current gastric, duodenal or oesophageal ulcers * Inflammatory disease of the gastrointestinal tract including oesophagitis, or specific inflammation such as Crohn's disease * Known potential upper gastrointestinal bleeding conditions such as gastric or oesophageal varices * Known structural abnormalities of the pharynx or oesophagus * Symptoms suggestive for severe gastric motility disorder * Known hiatus hernia ≥ 5 cm * Cancer diagnosed within the last 5 years or ongoing treatment for cancer (except non-metastasising skin cancer) * Known severe heart failure (NYHA 3-4) * Known chronic obstructive pulmonary disease (FEV1 ≤ 50 percent) * Kidney failure (eGFR ≤ 30 ml/min) * Liver failure (liver enzymes more than 3 times the normal threshold) * Known proliferative retinopathy * Known or suspected abuse of alcohol or narcotics * Current or history of systemic treatment with corticosteroids within the last 3 months * Known myocardial infarction or stroke within the last 6 months * Current or history of pancreatitis * Pregnancy, intention to become pregnant or breastfeeding during the study * Untreated or insufficient treated hypo- or hyperthyroidism * Current use of anti…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Weight loss in percent of total body weight

Timeframe: Change from baseline at 12 months

Trial details

NCT IDNCT04230655

SponsorRegion Örebro County

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12

Contact for this trial

Marije Galavazi, PhD, MD

+46196026631 marije.galavazi@regionorebrolan.se

View on ClinicalTrials.gov More Obesity trials