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The objectives of the study are to conduct a randomized controlled trial to test the efficacy of the Smartphone intervention on % weight loss and maintaining % weight loss at 6 and 12 months in a sample (N=256) of Black community college students who are overweight or obese, ages 18-25 years. Investigators will also examine mediating variables of the intervention on weight at 6 and 12 months, including adherence to self-monitoring, discrimination, and dietary and physical activity self-efficacy. In addition, investigators will explore potential moderators of weight loss at 6 months and 12 months, including depressive symptoms, ideal body image, and motivation.
A total of 256 students, ages 18-25, who meet the inclusion and exclusion criteria will be recruited from Columbus State Community College (CSCC). A sample size of 256 subjects (n=128 per each trial arm) will have sufficient power (>80%) to detect an average between-group difference with a moderate effect size of 0.4. The mixed effect modeling for repeated outcome measures at 6 and 12 months was used for the power calculation using two-sided significance level of 0.05 assuming 1) first-order autoregressive covariance structure, 2) the within-structure correlation of 0.8, and 3) 20% attrition rate at 12-month follow-up. The effect size of 0.4 was reasonably assumed based on data from published trials on weight-loss interventions (an effect size of 0.8 using 8-week social media, 0.3 using 12-week Smartphone intervention, and 0.6 using 4-month text messaging). Investigators will conduct stratified recruitment by gender (female vs. male) and ethnicity (Non-Hispanic Black vs. Hispanic Black) to achieve a study sample with 80% Non-Hispanic Black and 20% Hispanic and 50% male in each ethnic group. The recruitment and randomization will be equally distributed with approximately 10 subjects per month, which is a feasible enrollment target considering the pool of eligible participants and our previous recruitment success.
Prospective participants who contact through telephone or email will undergo a preliminary screening via telephone and receive an explanation of the study. Included in this screening are four questions from the Eating Attitude Test-26 (EAT-26), which will be asked to determine symptoms of disordered eating in the past 6 months. Those who seem to meet eligibility criteria and are interested in participating will be scheduled for an in person visit for the informed consent and screening process.
Following the informed consent process and baseline visit questionnaires, participants will be randomly assigned to intervention or the attention-control group. Investigators will use stratified randomization by sex (female vs. male) and ethnicity (Non-Hispanic Black vs. Hispanic Black). For each gender strata, randomization will occur in permuted blocks of varying block sizes. Subjects in each block will be randomly assigned to intervention arm or attention-control arm with an allocation ratio of 1:1. The advantage of permuted block randomization is that it will ensure balance in the number of subjects in the two trial arms during the entire study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Health coach with Smartphone application for diet and physical activity |
|
| Control | No Intervention | No intervention, using a Smartphone application for sleep monitoring |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone + Text Messaging with Health Coach | Behavioral | The program includes (1) use of a free commercially available smartphone application program for 12 months, (2) a wearable Fitbit Charge device that will be provided by the study to monitor active minutes, and (3) one 45-minute behavioral counseling session focused on healthy eating and exercise and (4) personalized text messaging for 6 months by a health coach. The health coach will not send feedback during months 6-12. The intervention will be fully self-directed in these months, as there will be no contact between the 6 months visit and 12-month visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Body weight will be measured in light clothing without shoes using the Tanita Body Scale (BS) | Baseline to 12 months |
| Physical Activity-Active Minutes/Day | Will be measured objectively using the FitBit Charge for 7 days at each time period of data collection. Average active minutes per day will be used as measurement. This data represents active minutes per day at 12 months | 12 months |
| Physical Activity-Steps/Day | Will be measured objectively using the FitBit Charge for 7 days at each time period of data collection. Average steps taken per day will be used as measurement. | 12 months |
| Food Frequency Questionnaire (FFQ) | The full-length block FFQ will be used to assess diet for 7 days at each period of data collection. This is not a scale, this is a measure of foods consumed over a period of 7 days. We measured and target sodium as the nutrient of choice to analyze | 12 months |
| Healthy Eating Index (HEI) | A healthy eating index score will be calculated at each time period from the FFQ. The scale ranges from 0-100 with 100 being the best possible score indicating healthy diet aligning with key dietary recommendations. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Participants Who Are Adherent to Self-Monitoring | Intervention condition only. Adherence will be defined as those participants who enter at least 50% of their caloric goal on at least 80% of days (or 24 days per months). | Baseline to 12 months |
| Dietary Self-Efficacy Scale (Diet-SE) |
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Inclusion
Exclusion
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36070664 | Derived | Stephens J, Randolph J, Burke L, Miller C, Tan A, Buffington B, Melnyk B, Perkins A. A randomized controlled trial for reduction of risk factors for cardiovascular disease in young adults: Methods of the Aspire study. Contemp Clin Trials. 2022 Oct;121:106873. doi: 10.1016/j.cct.2022.106873. Epub 2022 Sep 5. | |
| 34389927 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Health coach with Smartphone application for diet and physical activity Smartphone + Text Messaging with Health Coach: The program includes (1) use of a free commercially available smartphone application program for 12 months, (2) a wearable Fitbit Charge device that will be provided by the study to monitor active minutes, and (3) one 45-minute behavioral counseling session focused on healthy eating and exercise and (4) personalized text messaging for 6 months by a health coach. The health coach will not send feedback during months 6-12. The intervention will be fully self-directed in these months, as there will be no contact between the 6 months visit and 12-month visit. |
| FG001 | Control | No intervention, using a Smartphone application for sleep monitoring |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Health coach with Smartphone application for diet and physical activity Smartphone + Text Messaging with Health Coach: The program includes (1) use of a free commercially available smartphone application program for 12 months, (2) a wearable Fitbit Charge device that will be provided by the study to monitor active minutes, and (3) one 45-minute behavioral counseling session focused on healthy eating and exercise and (4) personalized text messaging for 6 months by a health coach. The health coach will not send feedback during months 6-12. The intervention will be fully self-directed in these months, as there will be no contact between the 6 months visit and 12-month visit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Body Weight | Body weight will be measured in light clothing without shoes using the Tanita Body Scale (BS) | Posted | Mean | Standard Deviation | Pounds | Baseline to 12 months |
|
|
Adverse event data was collected for the duration of the participant's time in the study, 12 months.
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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 | Intervention | Health coach with Smartphone application for diet and physical activity Smartphone + Text Messaging with Health Coach: The program includes (1) use of a free commercially available smartphone application program for 12 months, (2) a wearable Fitbit Charge device that will be provided by the study to monitor active minutes, and (3) one 45-minute behavioral counseling session focused on healthy eating and exercise and (4) personalized text messaging for 6 months by a health coach. The health coach will not send feedback during months 6-12. The intervention will be fully self-directed in these months, as there will be no contact between the 6 months visit and 12-month visit. |
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Limitations of this trial include being conducted at a single site, being limited to those who are aged 17-25 years, and being limited to those who own smartphones or devices. Additional limitations include unpredictability of health coaches in terms of messaging patients on time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandy Solove | Ohio State Univeristy | 6142478366 | solove.3@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2024 | Jan 15, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
14 questions that examine the participant's belief in their ability to cut down on high caloric foods. Scale ranges from 0-4 with 0 being "not at all confident" and 4 being "very confident" Higher overall score indicates higher levels of self confidence. Total score ranges from 0-56. Total score is reported. |
| 12 months |
| Self-Efficacy for Exercise Scale | 9 questions that examine the participant's belief in their ability to complete physical activity in given circumstances. Scale ranges from 0-10 with 0 being not at all confident and 10 being the most confident. Overall scores range from 0-90 with 90 indicating high confidence levels for exercise. | 12 months |
| Experiences of Discrimination Scale (EoD) | Examines perceived experiences of discrimination in given circumstances, such as work, public settings, banks, schools, medical care. 17 questions total. Scale ranges from never to four or more times. Four or more times being selected indicates higher levels of discrimination experiences. Total score reported. Higher score means higher levels of discrimination. Total score can range from 0 - 68 | 12 months |
| Patient Health Questionnaire (PHQ) for Adults, PHQ-9 | Measures depressive symptoms using the patient health questionnaire for adults. Questions are scored from 0-3, with lower scores indicating no/lower depressive symptoms. Total score can range from 0-27 | 12 months |
| Ideal Body Image | Measures patient perception of their current body image and their ideal body. image using a graphic scale ranging from 0-9, with 9 indicating higher levels of overweight/obesity. | 12 months |
| Treatment Self-Regulation Questionnaire (TSRQ) for Diet and Exercise | 30 questions to measure motivation to lose weight by examining three types of motivation. Scale ranges from 0-7 with 0 being "not at all" and 7 being "very true". A higher score indicates higher levels of motivation for diet and exercise habits. Total score can range from 0 - 210 | 12 months |
| NIH Patient Reported Outcome Measurement Information System (PROMIS) Measure for Emotional Support | 16 questions to measure perceived levels of emotional support. Scale ranges from 1-5 with 1 being "never" and 5 being "always. A higher level score indicates higher level of emotional support. Total scores can range from 16-80 | 12 months |
| Leissa SM, Randolph JC, Stephens JD. Recruitment of Black Identifying Young Adults into Clinical Trials: a Report from the Field. J Urban Health. 2021 Oct;98(Suppl 2):155-159. doi: 10.1007/s11524-021-00569-4. Epub 2021 Aug 13. No abstract available. |
| BG001 | Control | No intervention, using a Smartphone application for sleep monitoring |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | Pounds |
|
| Body Mass Index | Mean | Standard Deviation | weight (lb) ÷ height2 (inches) * 703 |
|
| Active Minutes Exercise | Mean | Standard Deviation | Minutes |
|
| Steps Exercise | Mean | Standard Deviation | Steps per day |
|
| Patient Health Questionnaire 9 | This is the patient health questionnaire 9 survey. Total score is reported. Scale ranges from 0-27. Higher values represents more depressive symptoms, thus we want to see lower scores. | Mean | Standard Deviation | Score on a scale |
|
| Participants |
|
|
| Primary | Physical Activity-Active Minutes/Day | Will be measured objectively using the FitBit Charge for 7 days at each time period of data collection. Average active minutes per day will be used as measurement. This data represents active minutes per day at 12 months | minutes/day | Posted | Mean | Standard Deviation | Minutes/day | 12 months |
|
|
|
| Primary | Physical Activity-Steps/Day | Will be measured objectively using the FitBit Charge for 7 days at each time period of data collection. Average steps taken per day will be used as measurement. | steps/day | Posted | Mean | Standard Deviation | Steps/day | 12 months |
|
|
|
| Primary | Food Frequency Questionnaire (FFQ) | The full-length block FFQ will be used to assess diet for 7 days at each period of data collection. This is not a scale, this is a measure of foods consumed over a period of 7 days. We measured and target sodium as the nutrient of choice to analyze | mg of sodium/day | Posted | Mean | Standard Deviation | Mg of sodium per day | 12 months |
|
|
|
| Primary | Healthy Eating Index (HEI) | A healthy eating index score will be calculated at each time period from the FFQ. The scale ranges from 0-100 with 100 being the best possible score indicating healthy diet aligning with key dietary recommendations. | Posted | Mean | Standard Deviation | Score on a scale | 12 months |
|
|
|
| Secondary | Rate of Participants Who Are Adherent to Self-Monitoring | Intervention condition only. Adherence will be defined as those participants who enter at least 50% of their caloric goal on at least 80% of days (or 24 days per months). | Intervention group who used app on or more than 80% of days to enter food | Posted | Count of Participants | Participants | Baseline to 12 months |
|
|
|
| Secondary | Dietary Self-Efficacy Scale (Diet-SE) | 14 questions that examine the participant's belief in their ability to cut down on high caloric foods. Scale ranges from 0-4 with 0 being "not at all confident" and 4 being "very confident" Higher overall score indicates higher levels of self confidence. Total score ranges from 0-56. Total score is reported. | 12 month total score | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Secondary | Self-Efficacy for Exercise Scale | 9 questions that examine the participant's belief in their ability to complete physical activity in given circumstances. Scale ranges from 0-10 with 0 being not at all confident and 10 being the most confident. Overall scores range from 0-90 with 90 indicating high confidence levels for exercise. | Total score at 12 months | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Secondary | Experiences of Discrimination Scale (EoD) | Examines perceived experiences of discrimination in given circumstances, such as work, public settings, banks, schools, medical care. 17 questions total. Scale ranges from never to four or more times. Four or more times being selected indicates higher levels of discrimination experiences. Total score reported. Higher score means higher levels of discrimination. Total score can range from 0 - 68 | Total score at 12 months | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Secondary | Patient Health Questionnaire (PHQ) for Adults, PHQ-9 | Measures depressive symptoms using the patient health questionnaire for adults. Questions are scored from 0-3, with lower scores indicating no/lower depressive symptoms. Total score can range from 0-27 | Total score at 12 months | Posted | Mean | Standard Deviation | Total score on scale | 12 months |
|
|
|
| Secondary | Ideal Body Image | Measures patient perception of their current body image and their ideal body. image using a graphic scale ranging from 0-9, with 9 indicating higher levels of overweight/obesity. | Ideal body image at 12 months | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Secondary | Treatment Self-Regulation Questionnaire (TSRQ) for Diet and Exercise | 30 questions to measure motivation to lose weight by examining three types of motivation. Scale ranges from 0-7 with 0 being "not at all" and 7 being "very true". A higher score indicates higher levels of motivation for diet and exercise habits. Total score can range from 0 - 210 | Score at 12 months | Posted | Mean | Standard Deviation | Score on survey | 12 months |
|
|
|
| Secondary | NIH Patient Reported Outcome Measurement Information System (PROMIS) Measure for Emotional Support | 16 questions to measure perceived levels of emotional support. Scale ranges from 1-5 with 1 being "never" and 5 being "always. A higher level score indicates higher level of emotional support. Total scores can range from 16-80 | Total Score at 12 months | Posted | Mean | Standard Deviation | Score on survey | 12 months |
|
|
|
| 0 |
| 128 |
| 0 |
| 128 |
| 0 |
| 128 |
| EG001 | Control | No intervention, using a Smartphone application for sleep monitoring | 0 | 128 | 0 | 128 | 0 | 128 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |