ObesityLiveWellRVANCT01899625
Motivational Interviewing for Weight Loss With Young Adults
A study testing Brief Behavioral Weight Loss (BWL) and Motivation Enhanced BWL in people with Obesity, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability and preliminary efficacy of an MI-based program for weight loss in young adults. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Obesity
- What is being tested?
- Brief Behavioral Weight Loss (BWL) and Motivation Enhanced BWL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Oct 2014
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 18-25 years of age.
- Body Mass Index (BMI) between 25 and 45 kg/m2.
- Men and women will be recruited.
- All race and ethnic groups will be recruited.
Who cannot join
- Currently receiving treatment for Type 2 Diabetes, hypertension, hyperlipidemia, or report a history of cardiovascular disease.
- Other health problems which may influence the ability to walk for physical activity or be associated with unintentional weight change, including cancer treatment within the past 5 years or tuberculosis.
- Report a history of, or current diagnosed DSM-IV-TR eating disorder (i.e., anorexia nervosa or bulimia nervosa) or any current compensatory behaviors (e.g., vomiting, laxative use, excessive exercise).
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
- Report a history of any psychotic disorder, bipolar disorder, or organic brain syndromes; report hospitalization for any psychiatric disorder within the last 12 months.
- Are currently participating in a weight loss program and/or taking weight loss medication.
Show all 11Show fewer
- Lost > 5% of body weight during the past 6 months or history of bariatric surgery.
- Participation in any other research study that may interfere with this study.
- Intend to move outside of the surrounding area within the time frame of the investigation or will be out of town / unavailable for three or more weeks during the initial intervention period.
- Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation.
- Failure to complete screening appointments. -
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University School of Medicine
Richmond, Virginia, 23298
About this study
Official title: Using Motivational Interviewing to Improve Weight Loss Outcomes With Young Adults
This study is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability and preliminary efficacy of an MI-based program for weight loss in young adults.
Read the detailed description
This study is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability and preliminary efficacy of an MI-based program for weight loss in young adults. Participants will be assigned to either the MI Behavioral Weigh Loss or Behavioral Weight Loss arms - both arms will receive a 12-week Behavioral Weight Loss program, including 2 individual in-person sessions, followed by weekly Behavioral Weight Loss modules, reporting of key behaviors, and feedback on progress relative to goals, all via email. Session content will be quite distinct between the two arms, with an increased emphasis on personalized feedback relative to healthy norms, enhancing autonomous motivation, and choice surrounding diet and activity goals in the MIBWL arm. Assessments will take place at 0, and 3 months, followed by exit interviews to help refine the protocol.
- Conditions
- Obesity
- Being tested
- Brief Behavioral Weight Loss (BWL), Motivation Enhanced BWL
- Keywords
- Obesity, weight loss, young adults
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Weight Loss (BWL)Behavioural
12 Week treatment program consisting of 2, 90-minute individual sessions, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Treatment consistent with behavioral weight loss, low calorie, low fat diet. Increased physical activity of up to 250 minutes/week.
Motivation Enhanced BWLBehavioural
12 week treatment program consisting of 2, 90-minute individual sessions with a focus on motivation, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Participants will pick from one of three dietary goals and one of three physical activity goals.
| Study group | Role | What they receive |
|---|---|---|
| Motivation Enhanced BWL | Active comparator | 12 week treatment program consisting of 2, 90-minute individual sessions with a focus on motivation, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Participants will pick from one of three dietary goals and one of three physical activity goals. Receives: Behavioral: Motivation Enhanced BWL |
| Brief Behavioral Weight Loss (BWL) | Active comparator | 12 Week treatment program consisting of 2, 90-minute individual sessions, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Treatment consistent with behavioral weight loss, low calorie, low fat diet. Increased physical activity of up to 250 minutes/week. Receives: Behavioral: Brief Behavioral Weight Loss (BWL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Primary Aims Include:
Primary Aim 1: To determine the feasibility of an MI-based approach to weight loss in young adults. Specifically, to demonstrate that we can: 1) recruit 18-25 year olds into the proposed program, 2) keep them engaged, as evidenced by achieving >80% attendance and >80% completion of tracking / reporting activities, and 3) retain them for assessments, as evidence by achieving >80% retention at 12 and 24 week visits.
Measured: 12 weeks
Adherence
Primary Aim 2: To explore whether the MIBWL arm produces better adherence (see Aim 1, item 2), retention, autonomous motivation, and satisfaction, all of which may be related to better weight losses in the long-term.
Measured: 12 weeks
Secondary outcomes (1)
Weight Loss
To explore whether the MIBWL arm is a viable approach to weight loss in this age group. Specifically, within group, we will examine mean weight change and proportion of participants achieving a clinically significant weight loss (>5%). Although not powered to detect differences, we will also explore differences in mean weight change between the MIBWL and BBWL groups.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startSep 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica G LaRose, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899625
- Sponsor's protocol ID
- HM14613
- Other IDs
- R03DK095959
- Acronym
- LiveWellRVA
- Status last verified
- Feb 2016
- First submitted
- 6 Jul 2013
- Last updated
- 26 Feb 2016
- 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 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Motivational Interviewing to Improve Weight Loss Outcomes With Young Adults
- ClinicalTrials.gov ID
- NCT01899625
- Acronym / sponsor ID
- LiveWellRVA / HM14613
- Conditions
- Obesity
- Keywords
- Obesity, weight loss, young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 15 Jul 2013 (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 is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability and preliminary efficacy of an MI-based program for weight loss in young adults.
Detailed description
This study is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability and preliminary efficacy of an MI-based program for weight loss in young adults. Participants will be assigned to either the MI Behavioral Weigh Loss or Behavioral Weight Loss arms - both arms will receive a 12-week Behavioral Weight Loss program, including 2 individual in-person sessions, followed by weekly Behavioral Weight Loss modules, reporting of key behaviors, and feedback on progress relative to goals, all via email. Session content will be quite distinct between the two arms, with an increased emphasis on personalized feedback relative to healthy norms, enhancing autonomous motivation, and choice surrounding diet and activity goals in the MIBWL arm. Assessments will take place at 0, and 3 months, followed by exit interviews to help refine the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivation Enhanced BWL | Active comparator | Behavioral: Motivation Enhanced BWL12 week treatment program consisting of 2, 90-minute individual sessions with a focus on motivation, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Participants will pick from one of three dietary goals and one of three physical activity goals. |
| Brief Behavioral Weight Loss (BWL) | Active comparator | Behavioral: Brief Behavioral Weight Loss (BWL)12 Week treatment program consisting of 2, 90-minute individual sessions, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Treatment consistent with behavioral weight loss, low calorie, low fat diet. Increased physical activity of up to 250 minutes/week. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 18-25 years of age.
- Body Mass Index (BMI) between 25 and 45 kg/m2.
- Men and women will be recruited.
- All race and ethnic groups will be recruited.
Key exclusion criteria (11 listed)
- Currently receiving treatment for Type 2 Diabetes, hypertension, hyperlipidemia, or report a history of cardiovascular disease.
- Other health problems which may influence the ability to walk for physical activity or be associated with unintentional weight change, including cancer treatment within the past 5 years or tuberculosis.
- Report a history of, or current diagnosed DSM-IV-TR eating disorder (i.e., anorexia nervosa or bulimia nervosa) or any current compensatory behaviors (e.g., vomiting, laxative use, excessive exercise).
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
- Report a history of any psychotic disorder, bipolar disorder, or organic brain syndromes; report hospitalization for any psychiatric disorder within the last 12 months.
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 |
|---|---|---|
| Brief Behavioral Weight Loss (BWL)12 Week treatment program consisting of 2, 90-minute individual sessions, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Treatment consistent with behavioral weight loss, low calorie, low fat diet. Increased physical activity of up to 250 minutes/week. | Behavioural | Brief Behavioral Weight Loss (BWL) |
| Motivation Enhanced BWL12 week treatment program consisting of 2, 90-minute individual sessions with a focus on motivation, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Participants will pick from one of three dietary goals and one of three physical activity goals. | Behavioural | Motivation Enhanced BWL |
Primary outcome
Feasibility
Time frame: 12 weeks
Primary Aims Include: Primary Aim 1: To determine the feasibility of an MI-based approach to weight loss in young adults. Specifically, to demonstrate that we can: 1) recruit 18-25 year olds into the proposed program, 2) keep them engaged, as evidenced by achieving >80% attendance and >80% completion of tracking / reporting activities, and 3) retain them for assessments, as evidence by achieving >80% retention at 12 and 24 week visits.
Adherence
Time frame: 12 weeks
Primary Aim 2: To explore whether the MIBWL arm produces better adherence (see Aim 1, item 2), retention, autonomous motivation, and satisfaction, all of which may be related to better weight losses in the long-term.
1 secondary outcome
Weight Loss
Time frame: 12 weeks
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 26 Feb 2016.
- 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.
Jessica G LaRose, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Weight Loss (BWL) and Motivation Enhanced BWL in people with Obesity, run by Virginia Commonwealth 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 4 inclusion and 11 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 26 Feb 2016. 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?
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?
Feasibility (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 Feb 2016.