ObesityPhase 2NCT00680979
Preventing Excessive Weight Gain in Adolescent Girls at High-Risk for Adult Obesity
A Phase 2 study testing Interpersonal Psychotherapy and Health Education in people with Obesity and Overweight, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
Trial summary
This study will examine whether interpersonal psychotherapy (IPT) can help reduce excessive weight gain in adolescent girls. It will compare the effectiveness of IPT with a teen health education program in preventing weight gain. Read more about this study
- Who is it for?
- Ages 12 to 17 years, women only
- Conditions the study is for
- Obesity, Overweight, Binge Eating
- What is being tested?
- Interpersonal Psychotherapy and Health Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 166 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 May 2008to 16 Apr 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Volunteers will qualify if they meet the following criteria.
- Female.
- Age 12 17 years.
- BMI between 75th and 97th percentile.
- English speaking.
- Good general health.
- Participants must have normal laboratory testing, including negative urine glucose and normal electrolytes, hepatic, and thyroid function, or they will be referred for treatment.
Who cannot join
- Individuals will be excluded (and referred to non-experimental treatment programs as needed):
- Presence of major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication). Non-serious medical illnesses, such as seasonal allergies, will be reviewed on a case-by-case basis.
- Presence of an obesity-related medical complication that would require a more aggressive weight loss intervention approach. Such comorbidities include hyperlipidemia (LDL-cholesterol greater than 160 mg/dL), hypertension (defined by age-, sex-, and height- specific standards fasting hyperglycemia (fasting glucose greater than 100 mg/dL) and nonalcoholic steatohepatitis (ALT above NIH Clinical Center laboratory norms with consistent radiologic findings and absence of another cause such as infectious hepatitis).
- Regular use of prescription medications. Oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting study. Individuals taking medications for most conditions will be excluded, but medication use for non-serious conditions (e.g., acne) will be considered on a case-by-case basis. In particular, participants currently prescribed SSRIs, neuroleptics, tricyclics, stimulants, or any medication known to affect body weight or eating will be excluded.
- Current involvement in psychotherapy or a structured weight loss program.
- Weight loss during the past 2 months for any reason exceeding 3 per cent of body weight.
Show all 12Show fewer
- Pregnant or recently pregnant girls (within 1 year of delivery).
- History of an eating disorder or a current eating disorder (other than binge eating disorder) as determined by medical history or if uncovered during the study s structured clinical interviews. Subjects found to have an eating disorder other than binge eating disorder at baseline will be referred to mental health specialists for further evaluation and treatment.
- Current pregnancy or breast feeding. A negative pregnancy test before starting the study will be required. Because pregnancy is a state in which weight gain is expected and appropriate, pregnant individuals would not be suitable for this study. Sexually active females must be using an effective form of birth control. These methods include total abstinence (no sex), oral contraceptives ( the pill ), an intrauterine device (IUD), levonogestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended. Should a participant in the IPT-WG group become pregnant during the 12 weeks of therapy, she will be excluded from the group sessions. The girl s IPT-WG therapists will closely assist her in obtaining an appropriate referral to a community mental healthcare provider. The IPT-WG leaders will request a release of information so that they may communicate with the community therapist in order to facilitate a smooth transition for the girl.
- Individuals who have DSM-IV-TR major depressive disorder, psychoses, current substance or alcohol abuse, conduct disorder, or a diagnosed psychiatric disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study. Individuals whose parents or guardians have current substance abuse or a diagnosed psychiatric disorder or other condition that, in the opinion of the investigators, would impede adherence with the study.
- Inability to participate in a group due to psychiatric or cognitive functioning. School placement (e.g. grade level) will be used as an estimate of cognitive functioning. The decision to include or exclude subjects for this reason is left entirely to the discretion of the investigators.
- Any other condition in the adolescent or her parents or guardians that, in the opinion of the investigators, would impede compliance or possibly hinder completion of the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
United States Uniformed Health Service
Bethesda, Maryland, 20889
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
This study will examine whether interpersonal psychotherapy (IPT) can help reduce excessive weight gain in adolescent girls. It will compare the effectiveness of IPT with a teen health education program in preventing weight gain.
Adolescent girls between 12 and 17 years of age who are at risk for becoming overweight adults, by virtue of being above average weight and experiencing episodes of loss of control over eating, may be eligible for this study. Candidates are screened in two visits with the following procedures:
Read more
Visit 1
- Height and weight measurements.
- Interview and questionnaires about the child s general health, social and psychological functioning and eating patterns and behaviors.
Visit 2
- Physical examination, blood and urine tests.
- DXA scan to measure body fat, muscle and bone mineral content.
- Laboratory test meal. The child fills out a rating scale about her level of hunger and is then given a food buffet from which she is instructed to eat as much as she wants. Immediately after eating, the child again completes the hunger rating forms.
- Interview about the child s mood and psychological functioning.
Participants are assigned at random to either the IPT or teen health education program. All participants have a 1- to 1 1/2-hour individual session with a therapist, followed by 12 weekly group sessions of 1 1/2 hours each in their assigned program. They are assessed at the end of the program with questionnaires and body measurements. They return to the clinic after 6 months for body measurements, blood test, DXA scan, questionnaires, interview and a test meal, and again at 1 year for body measurements, questionnaires and a DXA scan.
Read the detailed description
The most prevalent disordered eating pattern described in overweight youth is loss of control (LOC) eating, during which individuals experience an inability to control the amount of food they are consuming. LOC eating appears to be associated cross-sectionally with greater adiposity in children and adolescents, and appears to predispose youth to gain weight or body fat above that expected due to normal growth, thus likely contributing to obesity in susceptible individuals. Interpersonal Psychotherapy (IPT), a form of psychotherapy that has been adapted for the treatment of eating disorders, has demonstrated efficacy in reducing binge eating episodes and inducing modest weight loss (or at least weight stabilization) among adults diagnosed with binge eating disorder. We adapted group IPT for the targeted prevention of excessive weight gain (IPT-WG) among adolescent girls. Our pilot data support the feasibility and acceptability of a 12-week group IPT-WG trial among adolescent girls at high risk for obesity who report LOC eating, and preliminary findings suggest that IPT-WG has the potential to prevent excessive weight gain. We now propose an adequately powered clinical trial to evaluate the efficacy of IPT-WG compared to a standard-of-care health education for stabilizing weight and body fat gain trajectories in 117 adolescent girls at high risk for adult obesity who report LOC eating. Participants will be randomly assigned to a 12-week group IPT-WG or health education group; anthropometric variables will be measured at baseline, immediately after, and for up to 1 year following the initiation of treatment. We will assess the efficacy of IPT-WG in improving social functioning and reducing negative mood, disturbed eating patterns, and emotional distress. We also aim to determine the impact of IPT-WG on objective measures of LOC eating during a test meal and on appetitive hormones.
- Conditions
- Obesity, Overweight, Binge Eating
- Being tested
- Interpersonal Psychotherapy, Health Education
- Keywords
- Prevention, Obesity, Binge Eating, Adolescents, Overweight, Weight Gain
- Medical subject headings
- Obesity, Overweight, Bulimia, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal PsychotherapyBehavioural
Health EducationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Girls with LOC eating will be randomly assigned to IPT-WG or HE to examine their expected BMI change based upon CDC BMI growth chart data versus their actual in BMI over the course of two years.
Measured: 1 year
Secondary outcomes (1)
Efficacy of IPT-WG in improving socia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study start15 May 2008
- Primary completion16 Apr 2015
- Study completion16 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jack A Yanovski, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680979
- Sponsor's protocol ID
- 080139
- Other IDs
- 08-CH-0139
- Status last verified
- 20 Aug 2015
- First submitted
- 17 May 2008
- Last updated
- 1 Oct 2019
- Results posted
- No
Publications
Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
PubMed 16595758Ogden CL, Kuczmarski RJ, Flegal KM, Mei Z, Guo S, Wei R, Grummer-Strawn LM, Curtin LR, Roche AF, Johnson CL. Centers for Disease Control and Prevention 2000 growth charts for the United States: improvements to the 1977 National Center for Health Statistics version. Pediatrics. 2002 Jan;109(1):45-60. doi: 10.1542/peds.109.1.45.
PubMed 11773541Whitaker RC, Wright JA, Pepe MS, Seidel KD, Dietz WH. Predicting obesity in young adulthood from childhood and parental obesity. N Engl J Med. 1997 Sep 25;337(13):869-73. doi: 10.1056/NEJM199709253371301.
PubMed 9302300Shank LM, Tanofsky-Kraff M, Radin RM, Shomaker LB, Wilfley DE, Young JF, Brady S, Olsen CH, Reynolds JC, Yanovski JA. Remission of loss of control eating and changes in components of the metabolic syndrome. Int J Eat Disord. 2018 Jun;51(6):565-573. doi: 10.1002/eat.22866. Epub 2018 Apr 1.
PubMed 29607525Tanofsky-Kraff M, Shomaker LB, Wilfley DE, Young JF, Sbrocco T, Stephens M, Brady SM, Galescu O, Demidowich A, Olsen CH, Kozlosky M, Reynolds JC, Yanovski JA. Excess weight gain prevention in adolescents: Three-year outcome following a randomized controlled trial. J Consult Clin Psychol. 2017 Mar;85(3):218-227. doi: 10.1037/ccp0000153. Epub 2016 Nov 3.
PubMed 27808536Radin RM, Tanofsky-Kraff M, Shomaker LB, Kelly NR, Pickworth CK, Shank LM, Altschul AM, Brady SM, Demidowich AP, Yanovski SZ, Hubbard VS, Yanovski JA. Metabolic characteristics of youth with loss of control eating. Eat Behav. 2015 Dec;19:86-9. doi: 10.1016/j.eatbeh.2015.07.002. Epub 2015 Jul 18.
PubMed 26210388Tanofsky-Kraff M, Shomaker LB, Wilfley DE, Young JF, Sbrocco T, Stephens M, Ranzenhofer LM, Elliott C, Brady S, Radin RM, Vannucci A, Bryant EJ, Osborn R, Berger SS, Olsen C, Kozlosky M, Reynolds JC, Yanovski JA. Targeted prevention of excess weight gain and eating disorders in high-risk adolescent girls: a randomized controlled trial. Am J Clin Nutr. 2014 Oct;100(4):1010-8. doi: 10.3945/ajcn.114.092536. Epub 2014 Aug 13.
PubMed 25240070
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Excessive Weight Gain in Adolescent Girls at High-Risk for Adult Obesity
- ClinicalTrials.gov ID
- NCT00680979
- Acronym / sponsor ID
- 080139
- Conditions
- Obesity, Overweight, Binge Eating
- Keywords
- Prevention, Obesity, Binge Eating, Adolescents, Overweight, Weight Gain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 15 May 2008
- Primary completion
- 16 Apr 2015 (actual)
- Study completion
- 16 Apr 2015 (actual)
- First posted
- 20 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine whether interpersonal psychotherapy (IPT) can help reduce excessive weight gain in adolescent girls. It will compare the effectiveness of IPT with a teen health education program in preventing weight gain.
Adolescent girls between 12 and 17 years of age who are at risk for becoming overweight adults, by virtue of being above average weight and experiencing episodes of loss of control over eating, may be eligible for this study. Candidates are screened in two visits with the following procedures:
Visit 1
- Height and weight measurements.
- Interview and questionnaires about the child s general health, social and psychological functioning and eating patterns and behaviors.
Visit 2
- Physical examination, blood and urine tests.
- DXA scan to measure body fat, muscle and bone mineral content.
- Laboratory test meal. The child fills out a rating scale about her level of hunger and is then given a food buffet from which she is instructed to eat as much as she wants. Immediately after eating, the child again completes the hunger rating forms.
- Interview about the child s mood and psychological functioning.
Participants are assigned at random to either the IPT or teen health education program. All participants have a 1- to 1 1/2-hour individual session with a therapist, followed by 12 weekly group sessions of 1 1/2 hours each in their assigned program. They are assessed at the end of the program with questionnaires and body measurements. They return to the clinic after 6 months for body measurements, blood test, DXA scan, questionnaires, interview and a test meal, and again at 1 year for body measurements, questionnaires and a DXA scan.
Detailed description
The most prevalent disordered eating pattern described in overweight youth is loss of control (LOC) eating, during which individuals experience an inability to control the amount of food they are consuming. LOC eating appears to be associated cross-sectionally with greater adiposity in children and adolescents, and appears to predispose youth to gain weight or body fat above that expected due to normal growth, thus likely contributing to obesity in susceptible individuals. Interpersonal Psychotherapy (IPT), a form of psychotherapy that has been adapted for the treatment of eating disorders, has demonstrated efficacy in reducing binge eating episodes and inducing modest weight loss (or at least weight stabilization) among adults diagnosed with binge eating disorder. We adapted group IPT for the targeted prevention of excessive weight gain (IPT-WG) among adolescent girls. Our pilot data support the feasibility and acceptability of a 12-week group IPT-WG trial among adolescent girls at high risk for obesity who report LOC eating, and preliminary findings suggest that IPT-WG has the potential to prevent excessive weight gain. We now propose an adequately powered clinical trial to evaluate the efficacy of IPT-WG compared to a standard-of-care health education for stabilizing weight and body fat gain trajectories in 117 adolescent girls at high risk for adult obesity who report LOC eating. Participants will be randomly assigned to a 12-week group IPT-WG or health education group; anthropometric variables will be measured at baseline, immediately after, and for up to 1 year following the initiation of treatment. We will assess the efficacy of IPT-WG in improving social functioning and reducing negative mood, disturbed eating patterns, and emotional distress. We also aim to determine the impact of IPT-WG on objective measures of LOC eating during a test meal and on appetitive hormones.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Volunteers will qualify if they meet the following criteria.
- Female.
- Age 12 17 years.
- BMI between 75th and 97th percentile.
- English speaking.
Key exclusion criteria (12 listed)
- Individuals will be excluded (and referred to non-experimental treatment programs as needed):
- Presence of major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication). Non-serious medical illnesses, such as seasonal allergies, will be reviewed on a case-by-case basis.
- Presence of an obesity-related medical complication that would require a more aggressive weight loss intervention approach. Such comorbidities include hyperlipidemia (LDL-cholesterol greater than 160 mg/dL), hypertension (defined by age-, sex-, and height- specific standards fasting hyperglycemia (fasting glucose greater than 100 mg/dL) and nonalcoholic steatohepatitis (ALT above NIH Clinical Center laboratory norms with consistent radiologic findings and absence of another cause such as infectious hepatitis).
- Regular use of prescription medications. Oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting study. Individuals taking medications for most conditions will be excluded, but medication use for non-serious conditions (e.g., acne) will be considered on a case-by-case basis. In particular, participants currently prescribed SSRIs, neuroleptics, tricyclics, stimulants, or any medication known to affect body weight or eating will be excluded.
- Current involvement in psychotherapy or a structured weight loss program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpersonal Psychotherapy | Behavioural | – |
| Health Education | Behavioural | – |
Primary outcome
Girls with LOC eating will be randomly assigned to IPT-WG or HE to examine their expected BMI change based upon CDC BMI growth chart data versus their actual in BMI over the course of two years.
Time frame: 1 year
1 secondary outcome
Efficacy of IPT-WG in improving socia
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Background: PubMed 16595758Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
- Background: PubMed 11773541Ogden CL, Kuczmarski RJ, Flegal KM, Mei Z, Guo S, Wei R, Grummer-Strawn LM, Curtin LR, Roche AF, Johnson CL. Centers for Disease Control and Prevention 2000 growth charts for the United States: improvements to the 1977 National Center for Health Statistics version. Pediatrics. 2002 Jan;109(1):45-60. doi: 10.1542/peds.109.1.45.
- Background: PubMed 9302300Whitaker RC, Wright JA, Pepe MS, Seidel KD, Dietz WH. Predicting obesity in young adulthood from childhood and parental obesity. N Engl J Med. 1997 Sep 25;337(13):869-73. doi: 10.1056/NEJM199709253371301.
- Derived from this study: PubMed 29607525Shank LM, Tanofsky-Kraff M, Radin RM, Shomaker LB, Wilfley DE, Young JF, Brady S, Olsen CH, Reynolds JC, Yanovski JA. Remission of loss of control eating and changes in components of the metabolic syndrome. Int J Eat Disord. 2018 Jun;51(6):565-573. doi: 10.1002/eat.22866. Epub 2018 Apr 1.
- Derived from this study: PubMed 27808536Tanofsky-Kraff M, Shomaker LB, Wilfley DE, Young JF, Sbrocco T, Stephens M, Brady SM, Galescu O, Demidowich A, Olsen CH, Kozlosky M, Reynolds JC, Yanovski JA. Excess weight gain prevention in adolescents: Three-year outcome following a randomized controlled trial. J Consult Clin Psychol. 2017 Mar;85(3):218-227. doi: 10.1037/ccp0000153. Epub 2016 Nov 3.
- Derived from this study: PubMed 26210388Radin RM, Tanofsky-Kraff M, Shomaker LB, Kelly NR, Pickworth CK, Shank LM, Altschul AM, Brady SM, Demidowich AP, Yanovski SZ, Hubbard VS, Yanovski JA. Metabolic characteristics of youth with loss of control eating. Eat Behav. 2015 Dec;19:86-9. doi: 10.1016/j.eatbeh.2015.07.002. Epub 2015 Jul 18.
- Derived from this study: PubMed 25240070Tanofsky-Kraff M, Shomaker LB, Wilfley DE, Young JF, Sbrocco T, Stephens M, Ranzenhofer LM, Elliott C, Brady S, Radin RM, Vannucci A, Bryant EJ, Osborn R, Berger SS, Olsen C, Kozlosky M, Reynolds JC, Yanovski JA. Targeted prevention of excess weight gain and eating disorders in high-risk adolescent girls: a randomized controlled trial. Am J Clin Nutr. 2014 Oct;100(4):1010-8. doi: 10.3945/ajcn.114.092536. Epub 2014 Aug 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack A Yanovski, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interpersonal Psychotherapy and Health Education in people with Obesity and Overweight, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Girls with LOC eating will be randomly assigned to IPT-WG or HE to examine their expected BMI change based upon CDC BMI growth chart data versus their actual in BMI over the course of two years. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00680979, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.