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

Primary Purpose

Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Behavioral Weight Loss Intervention

Minority Stress Intervention

Negative Body Image Intervention

Social Support Intervention

About this trial

This is an interventional other trial for Obesity focused on measuring Sexual minority women, LGBTQ health, Weight loss

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)).

Sites / Locations

Weight Control and Diabetes Research Center, The Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

Weight Loss Program Only

Weight Loss Program + Coping with Stress Program

Weight Loss Program + Coping with Stress Program + Body Image Program

Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program

Weight Loss Program + Body Image Program + Social Support Program

Weight Loss Program + Coping with Stress Program + Social Support Program

Weight Loss Program + Body Image Program

Weight Loss Program + Social Support Program

Arm Description

Participants complete an online behavioral weight loss 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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Intervention Acceptability

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05036187

First Posted

August 30, 2021

Last Updated

March 1, 2023

Sponsor

The Miriam Hospital

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

1. Study Identification

Unique Protocol Identification Number

NCT05036187

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

June 28, 2022 (Actual)

Study Completion Date

June 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Miriam Hospital

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Sexual minority women, LGBTQ health, Weight loss

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Model Description

After a pre-piloting phase (consisting of initial content piloting, interviews, and intervention refinement; anticipated n=12), participants (anticipated n=8) will receive the online weight loss treatment and will be randomized to receive 0-3 novel intervention 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. Enrollment for both the pre-piloting phases (anticipated n=12) and open pilot trial phase (anticipated n=8) are reported here.

Masking

None (Open Label)

Masking Description

There is no masking during the pilot phase where the goal is to improve the program's acceptability.

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Weight Loss Program Only

Arm Type

Experimental

Arm Description

Participants complete an online behavioral weight loss program.

Arm Title

Weight Loss Program + Coping with Stress Program

Arm Type

Experimental

Arm Description

Arm Title

Weight Loss Program + Coping with Stress Program + Body Image Program

Arm Type

Experimental

Arm Description

Arm Title

Weight Loss Program + Coping with Stress Program + Body Image Program + Social Support Program

Arm Type

Experimental

Arm Description

Arm Title

Weight Loss Program + Body Image Program + Social Support Program

Arm Type

Experimental

Arm Description

Arm Title

Weight Loss Program + Coping with Stress Program + Social Support Program

Arm Type

Experimental

Arm Description

Arm Title

Weight Loss Program + Body Image Program

Arm Type

Experimental

Arm Description

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.

Arm Title

Weight Loss Program + Social Support Program

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Behavioral Weight Loss Intervention

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Minority Stress Intervention

Other Intervention Name(s)

Coping with Stress Program

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Negative Body Image Intervention

Other Intervention Name(s)

Body Image Program

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Social Support Intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Intervention Acceptability

Description

Time Frame

Week 12 (post-treatment)

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Participants who currently self-identify as female are being recruited.

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)).

Facility Information:

Facility Name

Weight Control and Diabetes Research Center, The Miriam Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Learn more about this trial

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

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