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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DK121896-04 | U.S. NIH Grant/Contract | View source | |
| 2019-10343 | Other Identifier | Einstein - IRB ID |
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| Name | Class |
|---|---|
| New York City Department of Health and Mental Hygiene | OTHER_GOV |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of this study is to address the risk of diabetes among men by creating a Diabetes Prevention Program (DPP) tailored to men.
The rising epidemic of type 2 diabetes is a major cause of disability and death that disproportionately affects men. Compared to women, men have much worse health and higher death rates for several chronic conditions, including diabetes. The National Diabetes Prevention Program (NDPP) has been shown to help decrease the chances of developing type 2 diabetes. The NDPP has shown the value of lifestyle change for weight loss and diabetes prevention. The Power-Up study is being done because although the evidence points to the effectiveness of the Diabetes Prevention Program (DPP), men are less likely to be engaged or participate in DPP.
The Power-up study was designed to see whether a DPP tailored for men can help improve engagement, participation, and results for men. Participants will be randomized to either undergo the Power-Up or standard NDPP classes. An assessment of whether a DPP created for men will increase participation in the program and decrease the risk for diabetes as compared to the standard NDPP. Power-Up is designed to Aim 1) Assess the effect of Power-Up vs. standard care NDPP on percent weight loss among men at risk for diabetes; Aim 2) Compare engagement of minority men at risk for diabetes in Power-Up vs. standard care NDPP; and Aim 3) Evaluate the Reach, Effectiveness, Adoption, Implementation, and Costs of Power-Up using the RE-AIM framework. The Power-Up intervention is tailored to the needs and preferences of men and uses: a) men coaches; b) men-only groups; c) messaging tailored to be appreciated and motivational to men; d) adapted content that highlights issues relevant to men.
There are 22-28 classes over the course of 12 months for both Power-Up and standard NDPP. The classes are split into two phases which are called the core and the maintenance phases. The core phase of the program will consist of at least 16 classes over the first 6 months. After the core, participants will attend maintenance classes over the next 6 months. Participants will be asked over the course of the 12 months to complete surveys at three different times before, during, and after completing the classes.
The hypothesis is that men randomized to Power-Up will achieve significantly greater weight loss (% weight loss from baseline) at 16 weeks and 1 year than men randomized to the standard care, mixed-gender NDPP group (Aim 1). Evaluation of engagement and retention for Aim 2 is based on attendance records for Power-Up and NDPP sessions electronically collected by trained coaches and monitored by study staff. The standards will be followed for NDPP evaluation where engagement is defined as equal or greater than 4 core sessions attended and retention is defined as equal or greater than 9 sessions attended. There will be a collection of quantitative and qualitative data that will be rigorously evaluated: the reach of our recruitment, broader patient-important indicators of effectiveness, adoption at the practice level, and implementation of the intervention (Aim 3).
Enrollment consists of 300 participants through our health system partners. Men will be randomized 1:1 to either the Power-Up intervention arm or referred to the standard NDPP at their clinic site. Consistent with current Centers for Disease Control and Prevention (CDC) standards and current NDPP practices of our health system partners, telephone make-up sessions will be offered by coaches in both conditions to men who miss in-person sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Power-Up | Experimental | Participants randomized to this arm will undergo 16 classes tailored for men, that discuss food choices, physical activity, and managing stress over 6 months, which are called the core, and 6 classes over the following 6 months, which is called the maintenance phase. |
|
| Standard NDPP (National Diabetes Prevention Program) | No Intervention | Participants randomized to this arm will undergo 16 mixed gender classes that discuss food choices, physical activity, and managing stress over 6 months which are called the core and 6 classes over the following 6 months which is called the maintenance phase. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Men-Tailored DPP (Power-Up) | Other | Evaluating whether a diabetes prevention program (DPP) tailored for men (Power-Up) will show better or similar percent weight loss and retention than a standard mixed-gender DPP |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Weight Change Through 16 Sessions | The percent weight change through 16 sessions was compared. Mean percent weight change for each arm for all intent-to-treat (ITT) participants (i.e.. attended >=0 sessions), as well as those who were considered "Engaged" (i.e., attended >=4 sessions) or "Retained" (i.e., attended >=9 sessions), through 16 scheduled sessions, was determined. All data is crude and unadjusted with no imputation. | Up to 6 months, after the delivery of the 16th session (end of the core phase) |
| Percent Weight Change Through the 12 Month Trial | The percent weight change through 12 months was compared. Mean percent weight change for each arm for all intent-to-treat (ITT) participants (i.e., attended >=0 sessions), as well as those who were considered "Engaged" (i.e., attended >=4 sessions) or "Retained" (i.e., attended >=9 sessions), through 12 months, was determined. All data is crude and unadjusted with no imputation. | 12 Months (At end of maintenance phase) |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement of Men in Power-Up vs Standard National Diabetes Prevention Program | Engagement of men at risk for diabetes in Power-Up vs. Standard NDPP was compared based on the number of sessions attended. Engagement is characterized as attending >= 4 sessions. Counts and percentages of participants who attended at least 4 sessions in the first six months of the workshops are summarized by study arm. This is halfway through the entire trial. |
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Inclusion Criteria:
Exclusion Criteria:
We are only enrolling men.
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| Name | Affiliation | Role |
|---|---|---|
| Earle Chambers, PhD | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29540129 | Background | Walker EA, Weiss L, Gary-Webb TL, Realmuto L, Kamler A, Ravenell J, Tejeda C, Lukin J, Schechter CB. Power Up for Health: Pilot Study Outcomes of a Diabetes Prevention Program for Men from Disadvantaged Neighborhoods. Am J Mens Health. 2018 Jul;12(4):989-997. doi: 10.1177/1557988318758787. Epub 2018 Mar 15. | |
| 29540130 | Background | Realmuto L, Kamler A, Weiss L, Gary-Webb TL, Hodge ME, Pagan JA, Walker EA. Power Up for Health-Participants' Perspectives on an Adaptation of the National Diabetes Prevention Program to Engage Men. Am J Mens Health. 2018 Jul;12(4):981-988. doi: 10.1177/1557988318758786. Epub 2018 Mar 15. |
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The study team began with a total of N=11052 participants (Ps). We were unable to contact n=6235 Ps. Before screening, n=1489 Ps declined to participate, and n=486 Ps were lost to follow-up. During screening, n=476 Ps were ineligible, and n=1739 Ps were eligible and declined to consent. After consent, n=326 Ps were lost to follow-up and not randomized. Enrolled is defined, according to the protocol, as being randomized into one of the study arms. Only 301 Ps were randomized.
Using the electronic health record (EHR) systems of a large academic medical center and a network of small to medium independent primary care practices throughout New York City, Black and Latino men who met eligibility criteria for NDPP were identified and enrolled in a randomized controlled trial and assigned 1:1 to receive Power-Up or the standard, mixed-gender NDPP over 1 year via online videoconferencing. The participants were recruited over the phone.
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| ID | Title | Description |
|---|---|---|
| FG000 | Power-Up | Participants randomized to this arm underwent 16 classes tailored for men that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase. |
| FG001 | Standard NDPP (National Diabetes Prevention Program) | Participants randomized to this arm underwent 16 mixed gender classes that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Power-Up | Participants randomized to this arm underwent 16 classes tailored for men that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase. |
| BG001 | Standard NDPP (National Diabetes Prevention Program) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean age at Baseline |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Weight Change Through 16 Sessions | The percent weight change through 16 sessions was compared. Mean percent weight change for each arm for all intent-to-treat (ITT) participants (i.e.. attended >=0 sessions), as well as those who were considered "Engaged" (i.e., attended >=4 sessions) or "Retained" (i.e., attended >=9 sessions), through 16 scheduled sessions, was determined. All data is crude and unadjusted with no imputation. | The difference in participants is due to the available data. If a valid weight was not available at 16 weeks (within -2 weeks or +4 weeks), the participant was excluded. Analyses were split into Intent to treat (ITT), including all participants with valid weights, having attended >=4 sessions (Engaged), and >=9 sessions (Retained). All data is crude and unadjusted with no imputation. | Posted | Mean | Standard Error | percent weight change | Up to 6 months, after the delivery of the 16th session (end of the core phase) |
|
Approximately 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Power-Up | Participants randomized to this arm underwent 16 classes tailored for men that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Earle C. Chambers, PhD, MPH | Albert Einstein College of Medicine | 718-430-3057 | earle.chambers@einsteinmed.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 19, 2024 | Mar 3, 2026 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 24, 2022 | Mar 3, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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There will be 6 intervention cycles. Approximately 50 men will be randomized 1:1 to each study arm. There will be 4 control cycles for every intervention workshop. Therefore we will have 6 intervention workshops and 24 control workshops. The participants will be randomized to either undergo Power-Up or standard Diabetes Prevention Program sessions.
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| 6 Months (At end of the core phase) |
| Retention of Men in Power-Up vs Standard National Diabetes Prevention Program | Retention of men at risk for diabetes in Power-Up vs. Standard NDPP was compared based on the number of sessions attended. Participants are defined as "retained" if they attended >=9 more sessions. It is expected that men randomized to the Power-Up sessions will have greater engagement and retention rates than men randomized to standard care and referred to mixed-gender NDPP classes. Counts and percentages of participants who attended at least 9 sessions through the 12 months of workshops are summarized by study arm. | 12 Months (At end of the maintenance phase) |
| 29540131 | Background | Gary-Webb TL, Walker EA, Realmuto L, Kamler A, Lukin J, Tyson W, Carrasquillo O, Weiss L. Translation of the National Diabetes Prevention Program to Engage Men in Disadvantaged Neighborhoods in New York City: A Description of Power Up for Health. Am J Mens Health. 2018 Jul;12(4):998-1006. doi: 10.1177/1557988318758788. Epub 2018 Mar 15. |
| 40554781 | Result | Chambers EC, Walker EA, Schechter C, Gil E, Herbert T, Diaz K, Gonzalez J. Virtual Diabetes Prevention Program Tailored to Increase Participation of Black and Latino Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jun 24;14:e64405. doi: 10.2196/64405. |
Participants randomized to this arm underwent 16 mixed gender classes that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
|
| Age, Customized | Age of the participants when the first session took place. | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | All participants in this trial needed to self-identify as men in order to be eligible for the study. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Self-reported whether the participant identifies as Hispanic/Latino collected during the baseline questionnaire. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Self-reported race collected during baseline questionnaire. | Participants excluded, declined, or refused to answer the question. n=23. | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Has Health Insurance? | Participant self-reported response to having any type of health insurance coverage, including private health insurance or government plans such as Medicare or Medicaid. | Participant excluded, declined, or refused to answer the question. n=1 | Count of Participants | Participants | No |
|
| Source of Health Insurance | Participant self-reported source of health insurance used to pay for doctor or hospital bills. | Participants excluded, declined, or refused to answer the question. n=16 | Count of Participants | Participants | No |
|
| Highest Level of Education Completed | Self-reported highest level of education completed during baseline questionnaire. | Participant excluded, declined, or refused to answer the question. n=1 | Count of Participants | Participants | No |
|
| Employment Status | Self-reported current employment status during baseline questionnaire | Count of Participants | Participants | No |
|
| Ever Smoked | Self-reported history of ever having smoked. Assessed during the baseline questionnaire. | Count of Participants | Participants | No |
|
| Current Smoking Frequency | Self-reported current smoking frequency at baseline. | Participant excluded, declined, or refused to answer the question. n=2 | Count of Participants | Participants | No |
|
| Marital Status | Self-reported marital status during baseline questionnaire. | Count of Participants | Participants |
|
| Household Income | Self-reported household income, from all sources, during baseline questionnaire. Reported by pre-specified income brackets. | Count of Participants | Participants | No |
|
| Number of People Supported on Household Income | The mean number of people being supported by the self-reported household income was assessed during administration of the baseline questionnaire. Data is summarized using basic descriptive statistics. | Participants who declined to provide income information were excluded from these analyses. n=74 | Mean | Standard Deviation | People |
|
| Born in US | Self-report whether participants were born in the US or outside of the US. | Count of Participants | Participants | No |
|
| Personal Health Questionnaire (PHQ-8) score | Depression was assessed using the 8-item Personal Health Questionnaire (PHQ-8). The PHQ-8 is a self-report screening tool wherein participants are asked to rate a series of statements based on how they felt over the prior 2 weeks on a scale ranging from 0 = Not at all; to 3 = Nearly every day, yielding an overall possible scoring range of 0-24, such that higher scores are indicative of greater depression severity. A total score of >=10 is generally considered the threshold for major depression. Missing items in the questionnaire were rescored using Ipsative Mean Imputation. | Mean | Standard Deviation | score on a scale |
|
| Delay between Randomization and Start | The mean number of days between being randomized and starting the assigned intervention. Data is summarized using basic descriptive statistics. | Mean | Standard Deviation | days |
|
| Life Difficulty from PHQ-8 Symptoms | During baseline participants were assessed as to how difficult it was to deal with PHQ-8-related symptoms using the following ordinal scale: Not at all difficult; Somewhat difficult; Very difficult; or Extremely difficult. Participant responses were summarized by assigned study arm. | Participants who did not have any PHQ-8 symptoms during the baseline questionnaire were excluded. n=65 | Count of Participants | Participants | No |
|
| Baseline Weight | This weight was recoded at the end of the baseline interview. The weight was confirmed via photo or through a web-based platform using Global System for Mobile Communications (GSM)-connected scales. | Mean | Standard Deviation | Pounds |
|
| Baseline Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
Participants randomized to this arm underwent 16 classes tailored for men that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase. |
| OG001 | Standard NDPP (National Diabetes Prevention Program) | Participants randomized to this arm underwent 16 mixed gender classes that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase. |
|
|
|
| Primary | Percent Weight Change Through the 12 Month Trial | The percent weight change through 12 months was compared. Mean percent weight change for each arm for all intent-to-treat (ITT) participants (i.e., attended >=0 sessions), as well as those who were considered "Engaged" (i.e., attended >=4 sessions) or "Retained" (i.e., attended >=9 sessions), through 12 months, was determined. All data is crude and unadjusted with no imputation. | The difference in participants is due to the available data. If a valid weight was not available at 12 months (within -2 or +4 weeks), the participant was excluded. Analyses were split into Intent to treat including all participants with valid weights, having attended >=4 sessions (Engaged), and >=9 sessions (Retained). | Posted | Mean | Standard Error | percent weight change | 12 Months (At end of maintenance phase) |
|
|
|
|
| Secondary | Engagement of Men in Power-Up vs Standard National Diabetes Prevention Program | Engagement of men at risk for diabetes in Power-Up vs. Standard NDPP was compared based on the number of sessions attended. Engagement is characterized as attending >= 4 sessions. Counts and percentages of participants who attended at least 4 sessions in the first six months of the workshops are summarized by study arm. This is halfway through the entire trial. | Posted | Count of Participants | Participants | 6 Months (At end of the core phase) |
|
|
|
|
| Secondary | Retention of Men in Power-Up vs Standard National Diabetes Prevention Program | Retention of men at risk for diabetes in Power-Up vs. Standard NDPP was compared based on the number of sessions attended. Participants are defined as "retained" if they attended >=9 more sessions. It is expected that men randomized to the Power-Up sessions will have greater engagement and retention rates than men randomized to standard care and referred to mixed-gender NDPP classes. Counts and percentages of participants who attended at least 9 sessions through the 12 months of workshops are summarized by study arm. | Posted | Count of Participants | Participants | 12 Months (At end of the maintenance phase) |
|
|
|
|
| 1 |
| 155 |
| 0 |
| 155 |
| 0 |
| 155 |
| EG001 | Standard NDPP (National Diabetes Prevention Program) | Participants randomized to this arm underwent 16 mixed gender classes that discussed food choices, physical activity, and managing stress over 6 months, defined as the core phase, and 8 classes over the following 6 months, defined as the maintenance phase. | 0 | 146 | 0 | 146 | 0 | 146 |
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| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |
| Unknown or Not Reported |
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| American Indian/Alaska Native |
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| Pacific Islander/Native Hawaiian |
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| White |
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| Other |
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| Don't Know/Not Sure |
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| Other/Unknown |
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| Private |
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| High School/Preparatory School |
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| Some College |
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| Trade School/Vocational School |
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| University/College |
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| Retired |
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| Perform volunteer work |
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| Not working, unable to work |
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| Not working, not looking for work |
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| Not working, but looking for work |
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| Not Reported |
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| Not at all |
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| Living with a partner |
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| Divorced |
|
| Separated |
|
| Widow(er) |
|
| Declined to answer |
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| Very difficult |
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| Extremely difficult |
|
| Intent to Treat Engaged (Attended >=4 Sessions) |
|
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| Intent to Treat Retained (Attended >= 9 Sessions) |
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|
Compared the mean percent change between treatment arms for Intent to Treat Engaged (Attended >=4 Sessions). Compared Power-Up mean percent change to Standard NDPP mean percent change. |
| Mean Difference (Net) |
| -0.0 |
| 2-Sided |
| 95 |
| -8.6 |
| 8.5 |
| Equivalence |
Power Up is an equivalence trial, and the equivalence margin for weight change is 2.5 percentage points from 0. (See citation https://doi.org/10.2196/64405) |
| Compared the mean percent change between treatment arms for Intent to Treat Retained (Attended >=9 Sessions). Compared Power-Up mean percent change to Standard NDPP mean percent change. | Mean Difference (Net) | 0.0 | 2-Sided | 95 | -9.4 | 9.5 | Equivalence | Power Up is an equivalence trial, and the equivalence margin for weight change is 2.5 percentage points from 0. (See citation https://doi.org/10.2196/64405) |