Weight LossNCT02966431
Effects of a Weight Loss Intervention in College-age Women
A study testing Counseling and No Counseling in people with Weight Loss, run by Texas Christian University at 1 site in United States.
Trial summary
Determine the effects of an 8-week weight loss intervention. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Counseling and No Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jul 2017
- Phase
- Interventional
- 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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females age 18-25years
- Body Mass Index 25.0 to 29.9 kg/m2 (overweight)
- Agree to receive frequent contacts from investigators and communicate with program staff for up to 6 months
- Willing to measure blood glucose via finger prick test three to eight times per day for two weeks
- Able to give written informed consent
- Able to comply with study procedures
Who cannot join
- Unable or unwilling to give informed consent
- Travel plans that do not permit participation
- Pregnant or planning on becoming pregnant during the 6 months of participation in the study
- Weight loss or gain exceeding 5% of body weight in the past 3 months
- Current participation in a weight loss program
- Diagnosis of mental disorder or chronic disease
Show all 15Show fewer
- History of eating disorder such as anorexia nervosa, bulimia nervosa, or binge eating disorder (unless approved by program staff)
- History of surgery or procedure that could affect swallowing or digestion
- Any person who is on a medically prescribed diet
- Any current supplement use other than a daily multivitamin
- Any current metabolic medication use other than birth control
- Any bleeding disorders or blood clotting problems
- Anyone who has donated blood or plasma in the last 20 days
- Any tobacco or illicit drug users
- Anyone who has allergies to any of the components of the liquid meal
Trial locations and contacts
1 site in 1 country.
About this study
Determine the effects of an 8-week weight loss intervention.
Read the detailed description
The purpose of this study is three-fold: 1) Determine whether an 8-week, patient-centered, weight loss intervention can be successfully implemented in overweight, college-age females for promotion of weight loss and prevention of weight regain at 8-weeks, three months, and six months follow-up; 2) Determine the effects of the intervention on established markers of calorie restriction, energy expenditure and body composition; 3) Determine the effects of a liquid meal on physiological and subjective markers of hunger and satiety from pre- to post- 8wk intervention in the intervention group vs control group.
- Conditions
- Weight Loss
- Being tested
- Counseling, No Counseling
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
No CounselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Counseling | Experimental | Receive counseling for 8-wks Receives: Behavioral: Counseling |
| Control | Placebo comparator | Does not receive counseling for 8-wks Receives: Behavioral: No Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: Strict study protocol and lack of participant reimbursement was not advantageous and feasible as evidenced by the high rate of attrition.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jada Stevenson, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966431
- Sponsor's protocol ID
- CT2016JS2
- Status last verified
- Jul 2018
- First submitted
- 9 Nov 2016
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Weight Loss Intervention in College-age Women
- ClinicalTrials.gov ID
- NCT02966431
- Acronym / sponsor ID
- CT2016JS2
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strict study protocol and lack of participant reimbursement was not advantageous and feasible as evidenced by the high rate of attrition.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 17 Nov 2016 (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.
Determine the effects of an 8-week weight loss intervention.
Detailed description
The purpose of this study is three-fold: 1) Determine whether an 8-week, patient-centered, weight loss intervention can be successfully implemented in overweight, college-age females for promotion of weight loss and prevention of weight regain at 8-weeks, three months, and six months follow-up; 2) Determine the effects of the intervention on established markers of calorie restriction, energy expenditure and body composition; 3) Determine the effects of a liquid meal on physiological and subjective markers of hunger and satiety from pre- to post- 8wk intervention in the intervention group vs control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counseling | Experimental | Behavioral: CounselingReceive counseling for 8-wks |
| Control | Placebo comparator | Behavioral: No CounselingDoes not receive counseling for 8-wks |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Females age 18-25years
- Body Mass Index 25.0 to 29.9 kg/m2 (overweight)
- Agree to receive frequent contacts from investigators and communicate with program staff for up to 6 months
- Willing to measure blood glucose via finger prick test three to eight times per day for two weeks
- Able to give written informed consent
Key exclusion criteria (15 listed)
- Unable or unwilling to give informed consent
- Travel plans that do not permit participation
- Pregnant or planning on becoming pregnant during the 6 months of participation in the study
- Weight loss or gain exceeding 5% of body weight in the past 3 months
- Current participation in a 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 |
|---|---|---|
| Counseling | Behavioural | Counseling |
| No Counseling | Behavioural | Control |
Primary outcome
Body weight
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Strict study protocol and lack of participant reimbursement was not advantageous and feasible as evidenced by the high rate of attrition.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling and No Counseling in people with Weight Loss, run by Texas Christian University 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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 26 Jul 2018. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Strict study protocol and lack of participant reimbursement was not advantageous and feasible as evidenced by the high rate of attrition.). Results are not available in the source record.
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?
Body weight (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2018.