Low Intensity Weight Loss for Young Adults (REACH)

June 5, 2023 updated by: Virginia Commonwealth University
This is a 3-arm randomized controlled trial to test the efficacy of three novel motivational approaches to weight loss with 18-25 year olds. Participants will be 18-25 year olds with a BMI of 25-45 kg/m2, randomized to: 1) Behavioral Weight Loss (BWL), 2) BWL + Autonomous Motivation (BWL+Aut) or 3) BWL + Extrinsic Motivation (BWL+Ext). All arms will receive a 6-month behavioral weight loss intervention, followed by a 6-month no-treatment follow up period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A 3-arm randomized controlled trial will be conducted, the goal of which is to determine which group represents the most viable approach to behavioral weight loss treatment with 18-25 year olds. A total of 381 participants,18-25 years of age, with a BMI between 25 and 45 kg/m2 will be randomized to one of three groups: 1) Behavioral Weight Loss (BWL), 2) BWL + Autonomous Motivation (BWL+Aut) or 3) BWL + Extrinsic Motivation (BWL+Ext). All arms will receive a 24-week behavioral weight loss intervention, including personalized dietary, physical activity, and weight loss prescriptions. In addition, all arms will be followed for a 6 month no treatment follow-up period. Assessments of weight and secondary outcomes will occur in 0, 3, 6 and 12 months. The investigators will compare treatment effects, across all 3 arms at 6 months, and compare arms on weight loss maintenance at12 months. The investigators will also examine mediators of treatment outcomes consistent with the investigators theoretical framework.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
382

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 232398
        • Virginia Commonwealth University, School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Report an uncontrolled medical condition that may pose a safety issue given the recommendations for diet and unsupervised physical activity in the current study (e.g., uncontrolled hypertension). The investigators will refer individuals who have blood pressure levels >140 / 90 mmHg as part of baseline screening to their physician and exclude them from this study unless their treating physician determines s/he is a suitable candidate based on the specifics of the protocol and provides written medical consent for participation. Participants who report a history of or current treatment for medical conditions (e.g., hypertension, diabetes) will be asked to obtain MD consent to participate.
  • Other health problems or medications 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 heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q), which will be administered during prescreen. 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, or current diagnosis of anorexia nervosa or bulimia nervosa, or any current compensatory behaviors (e.g., vomiting, laxative use, excessive exercise).
  • Current symptoms of alcohol or substance dependence.
  • Planning to move from the area within the study period.
  • Currently pregnant, pregnant within the past 6 months, currently breastfeeding or planning to become pregnant within the next 12 months.
  • Hospitalization for depression or other psychiatric disorder within the past 12 months. History of psychotic disorder or bipolar disorder.
  • Another member of the household is a participant or staff member on this study.
  • Participation in another research study that may interfere with this study.
  • Currently participating in a weight loss program and/or taking weight loss medication or lost > 5% of body weight during the past 3 months.
  • Failure to complete the screening appointments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Behavioral Weight Loss (BWL)
24 week treatment program consisting of a single, 90-minute, in-person group session in week 1, and a single 45 minute individual in-person session in week two, followed by a 6 month technology mediated program. The program includes evidenced-based behavioral weight loss content, individualized diet and physical activity goals, weekly lessons as well as reporting of key behaviors and personalized feedback to aid in goal attainment.
Behavioral: Behavioral Weight Loss (BWL)
The intervention represents an adapted version of gold-standard evidence based adult behavioral weight loss that has been tailored specifically to meet the needs of 18-25 year olds. The program includes personalized dietary and physical activity prescriptions, training in behavioral strategies, weekly lesson content, and reporting of key behaviors and personalized feedback and coaching.
Active Comparator: BWL + Autonomous Motivation
24 week treatment program consisting of a single, 90-minute, in-person group session in week 1, and a single 45 minute individual in-person session in week two, followed by a 6 month technology mediated program. The program includes evidenced-based behavioral weight loss content, individualized diet and physical activity goals, weekly lessons as well as reporting of key behaviors and personalized feedback to aid in goal attainment. Participants in this arm will receive coaching that places an increased emphasis on their values and personal choices, and also have the option to attend several experiential group sessions that will help those interested to apply the material and skills they are being taught (e.g., cooking demonstration, circuit training class).
Behavioral: Behavioral Weight Loss (BWL)
The intervention represents an adapted version of gold-standard evidence based adult behavioral weight loss that has been tailored specifically to meet the needs of 18-25 year olds. The program includes personalized dietary and physical activity prescriptions, training in behavioral strategies, weekly lesson content, and reporting of key behaviors and personalized feedback and coaching.
Behavioral: BWL + Autonomous Motivation
The intervention represents an adapted version of gold-standard evidence based adult behavioral weight loss that has been tailored specifically to meet the needs of 18-25 year olds. The program includes personalized dietary and physical activity prescriptions, training in behavioral strategies, weekly lesson content, and reporting of key behaviors and personalized feedback and coaching. Participants in this arm will receive coaching that places an increased emphasis on their values and personal choices, and also have the option to attend several experiential group sessions that will help those interested to apply the material and skills they are being taught (e.g., cooking demonstration, circuit training class).
Active Comparator: BWL + Extrinsic Motivation
24 week treatment program consisting of a single, 90-minute, in-person group session in week 1, and a single 45 minute individual in-person session in week two, followed by a 6 month technology mediated program. The program includes evidenced-based behavioral weight loss content, individualized diet and physical activity goals, weekly lessons as well as reporting of key behaviors and personalized feedback to aid in goal attainment. Participants in this arm will have the opportunity to receive small monetary incentives in weeks 2-24 for tracking weight and calorie intake, and will be eligible for a raffle based on weight loss.
Behavioral: Behavioral Weight Loss (BWL)
The intervention represents an adapted version of gold-standard evidence based adult behavioral weight loss that has been tailored specifically to meet the needs of 18-25 year olds. The program includes personalized dietary and physical activity prescriptions, training in behavioral strategies, weekly lesson content, and reporting of key behaviors and personalized feedback and coaching.
Behavioral: BWL + Extrinsic Motivation
The intervention represents an adapted version of gold-standard evidence based adult behavioral weight loss that has been tailored specifically to meet the needs of 18-25 year olds. The program includes personalized dietary and physical activity prescriptions, training in behavioral strategies, weekly lesson content, and reporting of key behaviors and personalized feedback and coaching. Participants in this arm will have the opportunity to receive small monetary incentives in weeks 2-24 for tracking weight and calorie intake, and will be eligible for a raffle based on weight loss.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight Loss
Time Frame: 6 Months
Primary pre-specified outcome is weight change in kilograms from baseline to 6 months. Change in kg was used in power calculations.
6 Months
Percent Weight Loss
Time Frame: 6 Months
Pre-specified analyses to examine impact on weight include percent weight loss from baseline to 6 months
6 Months
Change in Body Mass Index
Time Frame: 6 Months
Change in body mass index (calculated as change in kg/m^2, weight in kilograms, height in meters) from baseline to 6 months.
6 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Waist Circumference
Time Frame: 6 Months
Change in waist circumference (in cm) from baseline to 6 months.
6 Months
Body Composition (percent fat mass)
Time Frame: 6 Months
Change in fat mass from baseline to 6 months, measured by bioelectrical impedance analysis.
6 Months
Blood Pressure
Time Frame: 6 Months
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to 6 months.
6 Months
Minutes of Moderate to Vigorous Physical Activity
Time Frame: 6 Months
Change in minutes of moderate-to-vigorous activity from baseline to 6 months as assessed by objective activity monitors (Actigraph).
6 Months
Dietary Intake
Time Frame: 6 Months
Change in fat intake, sugared beverage intake, alcohol intake, fruit and vegetable intake from baseline to 6 months as assessed by interviewer administered modules.
6 Months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight Loss Maintenance
Time Frame: 12 Months
Pre-specified analyses to examine overall weight loss maintenance include weight change in kilograms from baseline to 12 months and change in percent weight loss from baseline to 12 months. Please note that both indices were included in the same secondary aim for funding agency and approved.
12 Months
Long-term Change in Body Mass Index
Time Frame: 12 Months
Overall change in body mass index (calculated as change in kg/m^2) from baseline to 12 months.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jessica G LaRose, PhD, Virginia Commonwealth University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 27, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 8, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HM20002772
  • R01DK103668 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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