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Adolescent Weight Loss Surgery study

A pilot study to evaluate the benefit of intensive lifestyle intervention (low calorie diet and exercise) with or without bariatric (weight-reduction) surgery in high-risk adolescents with morbid obesity.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000650998
Enrollment
20
Registered
2020-06-05
Start date
2020-08-11
Completion date
2022-10-31
Last updated
2024-01-15

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 aim of this pilot study is to investigate the effect of bariatric (weight-reduction) surgery (laparoscopic sleevegastrectomy or gastric bypass)on weight loss and health status in a cohort of morbidly obese adolescent diabetic subjects. This study will run for a maximum of 1.5 years consisting of: 6-months pre-assessment / rehabilitation support; and follow up at one year. Each rehabilitation plan will be developed on a case-by-case basis utilising a “pool” of resources / providers as required. This pool of services will include: • Psychological assessment / support • Health literacy • Cultural support • Dietetic / nutritional support • Peer support / focus group meetings The aim is to recruit ten participants into the surgery group and ten into the control group. The control group will be formed by those participants who do not meet selection criteria for a bariatric procedure after the 12 week VLCD regimen. Control participants will continue with intensive lifestyle intervention/weight loss maintenance programme until the end of the study.

Interventions

The purpose of this pilot study is to investigate the effect of intensive lifestyle intervention with or without bariatric (weight-reduction) surgery on the incidence of pre-diabetes and diabetes in a cohort of high-risk morbidly obese adolescent subjects. After the screening and baseline assessments and confirmed diagnosis of diabetes/pre-diabetes, consented participants will receive a 12 week weight-loss regimen comprising Very Low Calorie Diet (VLCD) based on the Optifast weight loss Progra

The purpose of this pilot study is to investigate the effect of intensive lifestyle intervention with or without bariatric (weight-reduction) surgery on the incidence of pre-diabetes and diabetes in a cohort of high-risk morbidly obese adolescent subjects. After the screening and baseline assessments and confirmed diagnosis of diabetes/pre-diabetes, consented participants will receive a 12 week weight-loss regimen comprising Very Low Calorie Diet (VLCD) based on the Optifast weight loss Programme, psychological assessment and psychiatric evaluation if required, family counselling, cultural support, and dietetic assessment/counselling. This will be followed by a weight maintenance programme which has been tailored for the study. These programmes will be provided by the Diabetes Foundation Aotearoa team comprising diabetes nurse, dietician, health psychologist and support staff. 12 week weight-loss regimen comprises: Frequency: Optifast™programme group sessions conducted over a 12 week period, every 2 weeks for 1 hour in the evenings at the Manukau Super Clinic. Mode: These group sessions are face-to-face and include the participant and a support person(s). A private facebook group will be set up and the sessions recorded for those participants unable to attend. The programme is as follows: Weeks 1-2, 4 and 6 are – INTENSIVE Weeks 8, 10, and 12 are TRANSITION Note: the Koha (reimbursement to say thank you) will be in the form of a supermarket or petrol voucher and provided at every session. Curriculum for Optifast™ Program: INTENSIVE - Overview of what to expect from the /program - How to start. - Tips, tricks and surviving (including not self-sabotaging/pantry audit) - Drinking, vegetables, what’s allowed - Gentle activity session - What to do to stay on track, what to do when fall off track - Side effects, how to manage them - Contact details, motivation and advice between meetings - Provision of Initial Optifast™ supplies for 21-28 days. Other: - Opportunity to meet one- on- one with one of the nutritionist/dietitian/health psychologist. - Questions and answers - Facebook page introduction - Program details Weeks 4 to 6 – INTENSIVE - Programme as for week 1-2 and including: - Where we are in the program - How are people going - Share tips/hints/success stories - Gentle activity session - Weigh in (private) - Mini consult with dietician/nutritionist/health psychologist - Role model/success story (if suitable individual can be available) At this second group meeting, individuals will be provided with - Optifast™ Supplies for 14 days (if not self-ordering through some system yet to be set up) - Other supplies as needed...eg, Psyllium Other: - Questions and answers - Next steps Week 8, 10 and 12 TRANSITION - Introduction of 1 meal back into the day. This session will provide further information, motivation, and support. The core content of teaching will be the same as previous sessions and also include : - Where we are in the program - Time to start transitioning back towards healthy eating - What a healthy meal looks like (starter healthy eating information, relevant to program but setting the stage for general living later) After 12 weeks, those participants who meet criteria for surgery will be offered a laparoscopic gastric sleeve or gastric bypass procedure, which will be done by Dr Richard Babor (General Surgeon) at the Manukau Surgical Centre in Auckland. An estimated time for the procedure would be up to an hour. Health Psychologist assessment at week 12. Format: 1-hour individual session with Health Psychologist for all participants at Manukau Superclinic outpatient clinic. Health Psychologist will formally assess mental state and participant’s readiness to have bariatric surgery for those participants who qualify (e.g. age equal to 16 years) Medical assessments will be carried out by the study investigator at baseline and weeks 24-36.and psychological support provided by Health Psychologists associated with the Adolescent Diabetes Clinic. Weight maintenance programme will begin for those participants who do not fulfil the criteria for surgery and will begin at week 12, through weeks 24, 36 and 48. Curriculum of Weight Maintenance Program: Months 1, 3 and 6 Programme Overview Outcome: This session consolidates new habits and skills Format: 1-hour evening group session at Manukau Superclinic The core content of teaching will include: - Overview of what to expect/program - How are people doing with their new life - More on healthy diet for normal living - Benefits of Physical activity and what does it mean to different people - Physical activity session - Weight - Other to be determined - At this group meeting, individuals will be provided with - Voucher for petrol or groceries to thank participants for attending Other: - Opportunity to meet one-on-one with one of the nutritionist, dietitian, sports specialist. - Questions and answers SECOND MEDICAL REVIEW - week 24-36 Outcome: This session evaluates health status & identifies any new health issues Format: 20-minute session with Diabetes Specialist for all participants at Manukau Superclinic outpatient clinic. Diabetes Specialist will review clinical condition and management of diabetes

Sponsors

Aotearoa Clinical Trials
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
189 Months to 18 Years
Healthy volunteers
No

Inclusion criteria

1. Be aged between 15 years 9 months and 18 years inclusive 2. Have been diagnosed with morbid obesity defined as a body mass index (BMI) >35 kg/m2 at the baseline visit. 3. Have pre-diabetes or type 2 diabetes mellitus as confirmed by oral glucose tolerance test at the baseline visit. 4. Provide written informed consent to participate in the study

Exclusion criteria

1. History of type 1 diabetes defined as age of onset <20 years and/or history of continuous treatment with insulin since diagnosis and/or positive antibodies to glutamic acid decarboxylase [GAD] or islet tyrosine phosphatase 2 [IA2] at baseline. 2. History of drug or alcohol abuse 3. Pregnancy 4. Serious co-morbid conditions that are likely to affect survival 5. Any other disease or condition which in the opinion of the investigator could make them unsuitable for entry.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026