Refining Novel Culturally Tailored Behavioral Weight Loss Treatment Components for Sexual Minority Women With Obesity

March 1, 2023 updated by: The Miriam Hospital

Using the Multiphase Optimization Strategy to Optimize a Culturally Tailored Online Behavioral Weight Loss Intervention for Sexual Minority Women: Pilot Study

Obesity disproportionately impacts sexual minority women. Behavioral weight loss programs are the gold standard treatment for mild to moderate obesity. The investigators have developed an online behavioral weight loss program that is effective, low-cost, and highly scalable. However, existing research suggests that tailoring treatment to address 3 well-established weight loss barriers in sexual minority women will be critical for maximizing the relevance and efficacy of behavioral weight loss for this group. The goal of the first phase of this K23 is to develop 3 novel treatment components targeting sexual minority women's weight loss barriers (i.e., minority stress, low social support, and negative body image), to pilot the program in sexual minority women with overweight/obesity, and to conduct individual qualitative interviews to elicit feedback on the intervention's acceptability, cultural relevance, usability, and feasibility that will be used to refine the program. After a pre-piloting phase (consisting of initial content piloting, interviews, and intervention refinement; anticipated n=12), 8 participants will pilot the full 3-month weight loss program and will be randomized to pilot 0-3 novel tailored components (targeting minority stress, negative body image, and social support) over the 3-month period. Participants will complete quantitative and qualitative assessments of intervention acceptability and appropriateness post-treatment and the intervention will be refined.

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.

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.
28

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
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Weight Control and Diabetes Research Center, The Miriam Hospital

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Assigned female at birth and currently identify as female
  • Self-identify a minority sexual orientation (e.g.,lesbian, bisexual)
  • BMI>25kg/m2
  • 18-70 years old
  • Interested in losing weight
  • Regular internet and e-mail access
  • Fluent in English

Exclusion Criteria:

  • Significant weight loss within past 6 months (>5%)
  • Unable to participate in moderate physical activity
  • Currently enrolled in a weight loss program
  • Currently taking weight-loss medication
  • Currently pregnant or trying to get pregnant
  • Participated in a previous Phase of this study
  • Reports a serious mental/physical health condition that would increase potential risks of treatment to the participant (e.g., active symptoms of psychosis, suicidality, mania, alcohol/substance use, or a medical condition that is serious, active, unstable, and degenerative (e.g., CHF)).

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: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

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.
Experimental: Weight Loss Program Only
Participants complete an online behavioral weight loss program.
Behavioral: Behavioral Weight Loss Intervention
Rx Weight Loss: PRIDE is a fully automated online behavioral obesity treatment that is tailored for sexual minority women and involves viewing 12 online video lessons delivered each week, self-monitoring body weight, calorie intake, and physical activity levels, and receiving personalized automated weekly feedback on progress toward goals.
Experimental: Weight Loss Program + Coping with Stress Program
Participants complete (1) an online behavioral weight loss program and (2) an adjunctive intervention that teaches strategies for coping with stress & stigma due to weight, sexual orientation, and gender & its impact on weight loss.
Behavioral: Behavioral Weight Loss Intervention
Rx Weight Loss: PRIDE is a fully automated online behavioral obesity treatment that is tailored for sexual minority women and involves viewing 12 online video lessons delivered each week, self-monitoring body weight, calorie intake, and physical activity levels, and receiving personalized automated weekly feedback on progress toward goals.
Behavioral: Minority Stress Intervention
The Minority Stress Intervention is designed to help sexual minority women cope with stress and stigma (e.g., due to weight, sexual orientation, gender). In this program, participants watch online video lessons that teach cognitive and behavioral strategies for coping with minority stress so that it may have less of an influence on participants' weight and well-being.
Other Names:
  • Coping with Stress Program
Experimental: Weight Loss Program + Coping with Stress Program + Body Image Program
Participants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress & stigma due to weight, sexual orientation, and gender & its impact on weight loss, and (3) an adjunctive intervention for improving negative body image and reducing its impact on weight loss.
Behavioral: Behavioral Weight Loss Intervention
Rx Weight Loss: PRIDE is a fully automated online behavioral obesity treatment that is tailored for sexual minority women and involves viewing 12 online video lessons delivered each week, self-monitoring body weight, calorie intake, and physical activity levels, and receiving personalized automated weekly feedback on progress toward goals.
Behavioral: Minority Stress Intervention
The Minority Stress Intervention is designed to help sexual minority women cope with stress and stigma (e.g., due to weight, sexual orientation, gender). In this program, participants watch online video lessons that teach cognitive and behavioral strategies for coping with minority stress so that it may have less of an influence on participants' weight and well-being.
Other Names:
  • Coping with Stress Program
Behavioral: Negative Body Image Intervention
The Negative Body Image Intervention is designed to help participants improve their body image. In this program, participants will watch online video lessons that provide education on queer women's body image and teach cognitive and behavioral strategies for improving your body image (regardless of your weight) to reduce its influence on your health.
Other Names:
  • Body Image Program
Experimental: Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program
Participants complete (1) an online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress & stigma due to weight, sexual orientation, and gender & its impact on weight loss, (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (4) an adjunctive intervention for improving negative body image and reducing its impact on weight loss.
Behavioral: Behavioral Weight Loss Intervention
Rx Weight Loss: PRIDE is a fully automated online behavioral obesity treatment that is tailored for sexual minority women and involves viewing 12 online video lessons delivered each week, self-monitoring body weight, calorie intake, and physical activity levels, and receiving personalized automated weekly feedback on progress toward goals.
Behavioral: Minority Stress Intervention
The Minority Stress Intervention is designed to help sexual minority women cope with stress and stigma (e.g., due to weight, sexual orientation, gender). In this program, participants watch online video lessons that teach cognitive and behavioral strategies for coping with minority stress so that it may have less of an influence on participants' weight and well-being.
Other Names:
  • Coping with Stress Program
Behavioral: Negative Body Image Intervention
The Negative Body Image Intervention is designed to help participants improve their body image. In this program, participants will watch online video lessons that provide education on queer women's body image and teach cognitive and behavioral strategies for improving your body image (regardless of your weight) to reduce its influence on your health.
Other Names:
  • Body Image Program
Behavioral: Social Support Intervention
The Social Support Intervention provides online opportunities for participants to receive more social support as they work toward their weight loss goals. Participants receive education on the importance of social support for weight management, they can earn badges for completing program milestones, and they gain access to a private online forum to get support and advice from other participants.
Experimental: Weight Loss Program + Body Image Program + Social Support Program
Participants complete (1) an online behavioral weight loss program, (2) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts, and (3) an adjunctive intervention for improving negative body image and reducing its impact on weight loss.
Behavioral: Behavioral Weight Loss Intervention
Rx Weight Loss: PRIDE is a fully automated online behavioral obesity treatment that is tailored for sexual minority women and involves viewing 12 online video lessons delivered each week, self-monitoring body weight, calorie intake, and physical activity levels, and receiving personalized automated weekly feedback on progress toward goals.
Behavioral: Negative Body Image Intervention
The Negative Body Image Intervention is designed to help participants improve their body image. In this program, participants will watch online video lessons that provide education on queer women's body image and teach cognitive and behavioral strategies for improving your body image (regardless of your weight) to reduce its influence on your health.
Other Names:
  • Body Image Program
Behavioral: Social Support Intervention
The Social Support Intervention provides online opportunities for participants to receive more social support as they work toward their weight loss goals. Participants receive education on the importance of social support for weight management, they can earn badges for completing program milestones, and they gain access to a private online forum to get support and advice from other participants.
Experimental: Weight Loss Program + Coping with Stress Program + Social Support Program
Participants complete a (1) online behavioral weight loss program, (2) an adjunctive intervention that teaches strategies for coping with stress & stigma due to weight, sexual orientation, and gender & its impact on weight loss, and (3) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts.
Behavioral: Behavioral Weight Loss Intervention
Rx Weight Loss: PRIDE is a fully automated online behavioral obesity treatment that is tailored for sexual minority women and involves viewing 12 online video lessons delivered each week, self-monitoring body weight, calorie intake, and physical activity levels, and receiving personalized automated weekly feedback on progress toward goals.
Behavioral: Minority Stress Intervention
The Minority Stress Intervention is designed to help sexual minority women cope with stress and stigma (e.g., due to weight, sexual orientation, gender). In this program, participants watch online video lessons that teach cognitive and behavioral strategies for coping with minority stress so that it may have less of an influence on participants' weight and well-being.
Other Names:
  • Coping with Stress Program
Behavioral: Social Support Intervention
The Social Support Intervention provides online opportunities for participants to receive more social support as they work toward their weight loss goals. Participants receive education on the importance of social support for weight management, they can earn badges for completing program milestones, and they gain access to a private online forum to get support and advice from other participants.
Experimental: Weight Loss Program + Body Image Program
Participants complete (1) an online behavioral weight loss program and (2) an adjunctive intervention for improving negative body image and reducing its impact on weight loss.
Behavioral: Behavioral Weight Loss Intervention
Rx Weight Loss: PRIDE is a fully automated online behavioral obesity treatment that is tailored for sexual minority women and involves viewing 12 online video lessons delivered each week, self-monitoring body weight, calorie intake, and physical activity levels, and receiving personalized automated weekly feedback on progress toward goals.
Behavioral: Negative Body Image Intervention
The Negative Body Image Intervention is designed to help participants improve their body image. In this program, participants will watch online video lessons that provide education on queer women's body image and teach cognitive and behavioral strategies for improving your body image (regardless of your weight) to reduce its influence on your health.
Other Names:
  • Body Image Program
Experimental: Weight Loss Program + Social Support Program
Participants complete (1) an online behavioral weight loss program and (2) an adjunctive Social Support Intervention that provides participants with online opportunities to give and receive real-time social support for weight loss efforts.
Behavioral: Behavioral Weight Loss Intervention
Rx Weight Loss: PRIDE is a fully automated online behavioral obesity treatment that is tailored for sexual minority women and involves viewing 12 online video lessons delivered each week, self-monitoring body weight, calorie intake, and physical activity levels, and receiving personalized automated weekly feedback on progress toward goals.
Behavioral: Social Support Intervention
The Social Support Intervention provides online opportunities for participants to receive more social support as they work toward their weight loss goals. Participants receive education on the importance of social support for weight management, they can earn badges for completing program milestones, and they gain access to a private online forum to get support and advice from other participants.

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
Intervention Acceptability
Time Frame: Week 12 (post-treatment)
A measure of intervention acceptability adapted from the Acceptability of Intervention (AIM) measure will assess acceptability outcomes post-treatment. Qualitative data on intervention acceptability and cultural appropriateness will also be considered.
Week 12 (post-treatment)

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.
The Miriam Hospital

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 on Minority Health and Health Disparities (NIMHD)

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.
June 1, 2021

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.
June 28, 2022

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.
June 28, 2022

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).
August 30, 2021

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.
August 30, 2021

First Posted (Actual)

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.
September 5, 2021

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.
March 2, 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.
March 1, 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.
February 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.
  • 1550062
  • K23MD015092 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be shared as follows:

  • Results will be submitted to ClinicalTrials.gov within appropriate timelines.
  • Quantitative data will be published in peer-reviewed manuscripts that will be submitted to PubMed Central upon acceptance.
  • Study results will be presented to the scientific community at national conferences relevant to obesity and sexual minority health.
  • Aggregate quantitative data may be requested from other researchers 5 years after the completion of the primary endpoint by contacting Dr. Panza. If there are no restrictions imposed by institutional policies, local IRBs, or laws/regulations, the investigators will make de-identified data available to a requester within the context of a clear data-sharing agreement Qualitative data will not be shared other than de-identified qualitative data that is published as part of peer-reviewed manuscripts.

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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