Weight LossNCT03284788

Wellness Achieved Through Changing Habits (The WATCH Study)

A study testing ABT Weight Loss Intervention in people with Weight Loss and Obesity, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this pilot, feasibility study is to investigate the acceptability of an acceptance-based therapy healthy lifestyle intervention in adolescent girls with overweight/obesity. Read more about this study

Who is it for?: Ages 14 to 19 years, women only
Conditions the study is for: Weight Loss, Obesity, Overweight
What is being tested?: ABT Weight Loss Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 8 Aug 2018to 1 Oct 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 14 to 19 years
Women only
No healthy volunteers
Child, Adult

Who may be able to join

Adolescent girls between ages 14-19 with overweight or obesity above the 85th percentile for sex and age as determined by CDC growth charts

Who cannot join

Known pregnancy or plans to become pregnant in the next 2 years
Any condition prohibiting physical activity
A diagnosis of cardiovascular disease or diabetes
Have active cancer or cancer requiring treatment in the past 2 years
Have active or chronic infections (e.g., HIV or TB)
Have active kidney disease or lung disease

Show all 10Show fewer

An eating disorder or substance abuse disorder
Having begun a course of or changed the dosage of any medications known to affect appetite or body composition within the previous 3 months
Weight loss greater than or equal to 5% in the previous 6 months
If they do not follow the study plan

Trial locations and contacts

1 site in 1 country.

United States1 site

HealthStreet and University of Florida
Gainesville, Florida, 32608

Other trials in United States

About this study

The purpose of this pilot, feasibility study is to investigate the acceptability of an acceptance-based therapy healthy lifestyle intervention in adolescent girls with overweight/obesity.

Read the detailed description

Participants will attend 2 baseline clinic visits and adolescents will participate in an ABT healthy lifestyle intervention.

The intervention will include 15 sessions over 6 months.

A post-treatment visit will occur.

Conditions: Weight Loss, Obesity, Overweight
Being tested: ABT Weight Loss Intervention
Keywords: acceptance-based therapy, adolescents, weight, weight loss, obesity, overweight
Medical subject headings: Weight Loss, Obesity, Overweight, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABT Weight Loss InterventionBehavioural
This includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.

Study groups in NCT03284788
Study group	Role	What they receive
ABT Weight Loss Intervention	Experimental	Adolescent girls will attend healthy lifestyle sessions that include nutritional education and physical activity education and build skills in the areas of values clarification, mindfulness, self-regulation skills, acceptance of uncomfortable states, goal-setting, problem solving, and self-monitoring. Receives: Behavioral: ABT Weight Loss Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Recruited
Number of teens who enrolled and completed both initial baseline visits. The recruitment strategy will be deemed 'feasible' if 15 participants are recruited within the 8 weeks.
Measured: Baseline; Week 8
Percentage of Participants Who Did Not Complete the Intervention.
The attrition strategy will be deemed "feasible" if there is less than 50% attrition at the end of the 6-month intervention. This percentage details attrition, or the percentage of participants who did not complete the intervention.
Measured: Baseline; Month 6
Percentage of Participants Who Decide to Participate in the Intervention
Of the participants who completed baseline visits, this percentage details what percentage of enrollees decided to participate in the intervention. The study will be deemed "acceptable" if at least 80% of enrolled participants decide to participate in the intervention.
Measured: Baseline; Week 1
Percentage of Participants Who Attend All Intervention Sessions.
This percentage details the percentage of those who attended all 15 intervention sessions among intervention completers (n=11). The study will be deemed 'acceptable' if at least 70% of intervention completers attend all sessions.
Measured: Week 1; Week 24

Secondary outcomes (1)

Change in BMI Z-score
Body mass index (BMI) z-scores are measures of weight adjusted for the height, age, and sex of the child. BMI z-scores correspond with growth chart percentiles. These scores are calculated with an external reference rather than internal references. In this study, the Centers for Disease Control and Prevention SAS program was used to calculate scores based on 2000 CDC growth charts. Additionally, a clinically significant change in BMI z-score was defined as greater than or equal to -0.15 as this decrease has shown improvements in one or more cardiovascular disease risk factor. The central z-score value is 0, representing the population mean, and standard deviations below the mean indicate better outcomes.
Measured: Baseline; Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Aug 20181 Oct 2020

First posted15 Sep 2017
Study start8 Aug 2018
Primary completion30 Jul 2020
Study completion1 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Weight LossStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03284788
Sponsor's protocol ID: IRB201701609-N
Other IDs: K01HL141535, PA-16-190
Status last verified: Sep 2023
First submitted: 29 Aug 2017
Last updated: 5 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Weight Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Wellness Achieved Through Changing Habits (The WATCH Study)
ClinicalTrials.gov ID: NCT03284788
Acronym / sponsor ID: IRB201701609-N
Conditions: Weight Loss, Obesity, Overweight
Keywords: acceptance-based therapy, adolescents, weight, weight loss, obesity, overweight
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: StayWell, National Heart, Lung, and Blood Institute (NHLBI), WellCare Health Plans, Inc.
Study start: 8 Aug 2018 (actual)
Primary completion: 30 Jul 2020 (actual)
Study completion: 1 Oct 2020 (actual)
First posted: 15 Sep 2017 (actual)
Results: Posted 5 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this pilot, feasibility study is to investigate the acceptability of an acceptance-based therapy healthy lifestyle intervention in adolescent girls with overweight/obesity.

Detailed description

Participants will attend 2 baseline clinic visits and adolescents will participate in an ABT healthy lifestyle intervention.

The intervention will include 15 sessions over 6 months.

A post-treatment visit will occur.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ABT Weight Loss Intervention	Experimental	Behavioral: ABT Weight Loss InterventionAdolescent girls will attend healthy lifestyle sessions that include nutritional education and physical activity education and build skills in the areas of values clarification, mindfulness, self-regulation skills, acceptance of uncomfortable states, goal-setting, problem solving, and self-monitoring.

Who may qualify

Ages: 14 to 19 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

Adolescent girls between ages 14-19 with overweight or obesity above the 85th percentile for sex and age as determined by CDC growth charts

Key exclusion criteria (10 listed)

Known pregnancy or plans to become pregnant in the next 2 years
Any condition prohibiting physical activity
A diagnosis of cardiovascular disease or diabetes
Have active cancer or cancer requiring treatment in the past 2 years
Have active or chronic infections (e.g., HIV or TB)

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
ABT Weight Loss InterventionThis includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.	Behavioural	ABT Weight Loss Intervention

Primary outcome

Number of Participants Recruited
Time frame: Baseline; Week 8
Number of teens who enrolled and completed both initial baseline visits. The recruitment strategy will be deemed 'feasible' if 15 participants are recruited within the 8 weeks.
Percentage of Participants Who Did Not Complete the Intervention.
Time frame: Baseline; Month 6
The attrition strategy will be deemed "feasible" if there is less than 50% attrition at the end of the 6-month intervention. This percentage details attrition, or the percentage of participants who did not complete the intervention.
Percentage of Participants Who Decide to Participate in the Intervention
Time frame: Baseline; Week 1
Of the participants who completed baseline visits, this percentage details what percentage of enrollees decided to participate in the intervention. The study will be deemed "acceptable" if at least 80% of enrolled participants decide to participate in the intervention.
Percentage of Participants Who Attend All Intervention Sessions.
Time frame: Week 1; Week 24
This percentage details the percentage of those who attended all 15 intervention sessions among intervention completers (n=11). The study will be deemed 'acceptable' if at least 70% of intervention completers attend all sessions.

1 secondary outcome

Change in BMI Z-score
Time frame: Baseline; Month 6

Results and safety

Results posted to the registry on 5 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABT Intervention	13	11

Primary outcome: Number of Participants Recruited

Time frame: Baseline; Week 8. Count of participants. Unit: Participants

Measure	ABT Weight Loss Intervention n = 60
Value	16

Population analysed: 60 participants were screened for eligibility. 43 were excluded (12 did not meet eligibility criteria; 31 declined to participate). 17 consented and 16 completed initial baseline visits. 13 decided to participate in the intervention. 11 received the allocated intervention and 2 did not (dropped out due to time constraints). Demographic variables were assessed among intervention participants, explaining the discrepancies between the results and participant flow sections.

Primary outcome: Percentage of Participants Who Did Not Complete the Intervention.

Time frame: Baseline; Month 6. Number. Unit: percentage of participants

Measure	ABT Weight Loss Intervention n = 13
Value	15.4

Population analysed: 17 participants consented; 16 participants completed the 2 initial baseline clinic visits. Of the 16 participants who completed baseline visits, 13 decided to participate in the intervention. 11 received the allocated intervention and 2 did not (dropped out due to time constraints). Demographic variables were assessed among intervention participants (n=13).This explanation provides insights to the discrepancies between the results and participant flow sections.

Primary outcome: Percentage of Participants Who Decide to Participate in the Intervention

Time frame: Baseline; Week 1. Number. Unit: percentage of participants

Measure	ABT Weight Loss Intervention n = 16
Value	81.3

Population analysed: 17 participants consented; 16 participants completed the 2 initial baseline visits. Of the 16 participants who completed baseline visits, 13 decided to participate in the intervention. Of the 13 participants who decided to participate in the intervention, 11 received the allocated intervention and 2 dropped out due to time constraints. This explanation provides insight to discrepancies between the results and participant flow.

Primary outcome: Percentage of Participants Who Attend All Intervention Sessions.

Time frame: Week 1; Week 24. Number. Unit: percentage of participants

Measure	ABT Weight Loss Intervention n = 11
Value	90.9

Population analysed: 17 participants consented; 16 participants completed the 2 initial baseline clinic visits. Of the 16 participants who completed baseline visits, 13 decided to participate in the intervention. Of the 13 participants who decided to participate in the intervention, 11 received the allocated intervention and 2 did not (dropped out due to time constraints). This explanation provides insight into discrepancies between the results

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected over the course of baseline through study completion [6 months].. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ABT Weight Loss Intervention	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Weight Loss

Not yet recruiting
Preserving Muscle Mass During Incretin-Induced Weight Loss
Obesity (BMI > 35)
Recruiting
Remote Approaches for Optimizing Weight Loss (Elevate Weight Loss Trial)
Obesity/Therapy
Active, not recruitingPhase 4
Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
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RecruitingObservational study
Hospital-Based Prospective Cohort of Malnutrition Under 6-Month Study (HOSPIC-6-Study)
Malnutrition, Infant, Malnutrition
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
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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.

Michelle I Cardel, PhD, MS, RD principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ABT Weight Loss Intervention in people with Weight Loss and Obesity, run by University of Florida at 1 site 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 1 inclusion and 10 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 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Recruited (time frame: Baseline; Week 8). The study lists 4 primary outcomes in all. 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 NCT03284788.

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 5 Oct 2023.