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Examining the reciprocal effects of stress-related eating on sleeve gastrectomy: a randomised controlled study in people seeking treatment for obesity

Examining the reciprocal effects of stress-related eating on sleeve gastrectomy: a randomised controlled study in people seeking treatment for obesity

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001697279
Enrollment
38
Registered
2018-10-15
Start date
2019-07-25
Completion date
2023-02-15
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The overall aim of this proposal is to explore the link between stress-related eating behavior and treatment outcomes in people undergoing treatment for obesity. Patients who have been referred for surgical treatment for obesity (sleeve gastrectomy) will be invited to participate in a study in which half of them will be randomly allocated to using a very-low-energy diet (VLED) for 2 months while waiting for surgery. Participants will complete questionnaires, and have a meal test (involving collection of blood samples prior to and for 2 hours after a liquid meal) at the beginning of the study, and three months after the intervention (VLED or surgery), and 12 months after surgery. We hypothesise that stress-related eating will improve after sleeve gastrectomy, and will be associated with one or more hormones involved in appetite regulation.

Interventions

Adults with obesity who are awaiting sleeve gastrectomy (SG) will be invited to participate. Intervention: Sleeve gastrectomy (SG) Participants will complete six validated questionnaires to assess non-homeostatic eating behaviours (such as stress-related eating, pleasure of eating), emotions and feelings. They will also have their weight recorded, and undergo a mixed meal test with a blood sample to assess appetite-regulating hormones at fasting and at 30, 60 and 120 mins post-prandially at base

Adults with obesity who are awaiting sleeve gastrectomy (SG) will be invited to participate. Intervention: Sleeve gastrectomy (SG) Participants will complete six validated questionnaires to assess non-homeostatic eating behaviours (such as stress-related eating, pleasure of eating), emotions and feelings. They will also have their weight recorded, and undergo a mixed meal test with a blood sample to assess appetite-regulating hormones at fasting and at 30, 60 and 120 mins post-prandially at baseline (pre-weight loss), and again 2 and 12 months post-intervention. Data collection will be performed by a qualified study doctor or research nurse, face-to-face*, individually. Sleeve gastrectomy, a type of surgery for weight loss that involves removal of around 85% of the stomach, will be performed by a qualified bariatric surgeon (expected operating time 1-2 hours). All study visits and procedures will be performed at Austin Health or St Vincent’s Hospital Melbourne *Addendum due to government and public health advice around social distancing and travel restrictions (as of 01 October 2021) To remain in line with local hospital and government public health guidance around social distancing and travel restrictions, visits for newly recruited participants may be conducted remotely. Questionnaires to assess non-homeostatic eating behaviours will be conducted via telephone or video conference. Participants who enter the study during the period of remote visits (i.e. remote visit 2) will not undergo a mixed meal test with blood samples and subjective appetite ratings. Participants already enrolled as of 01/10/2021 will be asked to complete their remaining study visits in-person (as described above), and a remote visit conducted only if they are unable or unwilling to do so.

Sponsors

Austin Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults with obesity who are awaiting sleeve gastrectomy

Exclusion criteria

Treatment for diabetes other than metformin Contraindication for bariatric surgery or very-low-energy diet Current use of appetite-reducing pharmacotherapy Previous bariatric surgery

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026