Obesity
Conditions
Keywords
minority, College Student, Nutrition, Physical Activity, Health Coach
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSmartphone + 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.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion * age 17-25 years * Current CSCC student * Identify as Black * BMI ≥ 25 * Speaks and reads English * Interested in losing weight through diet and physical activity changes * Owns a smartphone or iPhone Operating System (iOS) or Android compatible device * Ability to return for 12-month visit Exclusion * currently pregnant or planning to become pregnant in next 12 months * Currently participating in another structured weight loss program or taking weight loss medications or medication known to increase weight * Lost 10% or more of body weight in past 6 months * Screens positive for disordered eating symptoms * diagnosed with type I diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Baseline to 12 months | Body weight will be measured in light clothing without shoes using the Tanita Body Scale (BS) |
| Physical Activity-Active Minutes/Day | 12 months | 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 |
| Physical Activity-Steps/Day | 12 months | 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. |
| Food Frequency Questionnaire (FFQ) | 12 months | 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 |
| Healthy Eating Index (HEI) | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ideal Body Image | 12 months | 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. |
| Rate of Participants Who Are Adherent to Self-Monitoring | Baseline to 12 months | 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). |
| NIH Patient Reported Outcome Measurement Information System (PROMIS) Measure for Emotional Support | 12 months | 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 |
| Treatment Self-Regulation Questionnaire (TSRQ) for Diet and Exercise | 12 months | 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 |
| Dietary Self-Efficacy Scale (Diet-SE) | 12 months | 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. |
| Self-Efficacy for Exercise Scale | 12 months | 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. |
| Experiences of Discrimination Scale (EoD) | 12 months | 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 |
| Patient Health Questionnaire (PHQ) for Adults, PHQ-9 | 12 months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 128 |
| Control No intervention, using a Smartphone application for sleep monitoring | 128 |
| Total | 256 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| Active Minutes Exercise | 30.5 Minutes STANDARD_DEVIATION 40.4 | 28.9 Minutes STANDARD_DEVIATION 39.1 | 27.2 Minutes STANDARD_DEVIATION 37.8 |
| Age, Categorical <=18 years | 2 Participants | 4 Participants | 2 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 126 Participants | 252 Participants | 126 Participants |
| Body Mass Index | 32.8 weight (lb) ÷ height2 (inches) * 703 STANDARD_DEVIATION 7.1 | 33.2 weight (lb) ÷ height2 (inches) * 703 STANDARD_DEVIATION 6.4 | 33.3 weight (lb) ÷ height2 (inches) * 703 STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 45 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 106 Participants | 211 Participants | 105 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Patient Health Questionnaire 9 | 6.5 Score on a scale STANDARD_DEVIATION 4.8 | 6.6 Score on a scale STANDARD_DEVIATION 4.7 | 6.6 Score on a scale STANDARD_DEVIATION 4.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 90 Participants | 182 Participants | 92 Participants |
| Race (NIH/OMB) More than one race | 38 Participants | 74 Participants | 36 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 128 participants | 256 participants | 128 participants |
| Sex: Female, Male Female | 64 Participants | 128 Participants | 64 Participants |
| Sex: Female, Male Male | 64 Participants | 128 Participants | 64 Participants |
| Steps Exercise | 5553 Steps per day STANDARD_DEVIATION 4274 | 5503 Steps per day STANDARD_DEVIATION 4281 | 5452 Steps per day STANDARD_DEVIATION 4289 |
| Weight | 208.9 Pounds STANDARD_DEVIATION 49.2 | 209.4 Pounds STANDARD_DEVIATION 45.6 | 210.6 Pounds STANDARD_DEVIATION 43.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 128 | 0 / 128 |
| other Total, other adverse events | 0 / 128 | 0 / 128 |
| serious Total, serious adverse events | 0 / 128 | 0 / 128 |
Outcome results
Primary
Change in Body Weight
Body weight will be measured in light clothing without shoes using the Tanita Body Scale (BS)
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Body Weight | -2.5 Pounds | Standard Deviation 15.3 |
| Intervention | Change in Body Weight | -0.8 Pounds | Standard Deviation 17.2 |
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
Time frame: 12 months
Population: mg of sodium/day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Food Frequency Questionnaire (FFQ) | 3503 Mg of sodium per day | Standard Deviation 1205 |
| Intervention | Food Frequency Questionnaire (FFQ) | 4105 Mg of sodium per day | Standard Deviation 1100 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Healthy Eating Index (HEI) | 47 Score on a scale | Standard Deviation 6.8 |
| Intervention | Healthy Eating Index (HEI) | 48 Score on a scale | Standard Deviation 7.1 |
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
Time frame: 12 months
Population: minutes/day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Physical Activity-Active Minutes/Day | 9.7 Minutes/day | Standard Deviation 21 |
| Intervention | Physical Activity-Active Minutes/Day | 12.9 Minutes/day | Standard Deviation 24.2 |
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.
Time frame: 12 months
Population: steps/day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Physical Activity-Steps/Day | 2537 Steps/day | Standard Deviation 4333 |
| Intervention | Physical Activity-Steps/Day | 2659 Steps/day | Standard Deviation 3853 |
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.
Time frame: 12 months
Population: 12 month total score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Dietary Self-Efficacy Scale (Diet-SE) | 27.8 score on a scale | Standard Deviation 9.7 |
| Intervention | Dietary Self-Efficacy Scale (Diet-SE) | 25.4 score on a scale | Standard Deviation 10.1 |
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
Time frame: 12 months
Population: Total score at 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Experiences of Discrimination Scale (EoD) | 8.8 score on a scale | Standard Deviation 9.5 |
| Intervention | Experiences of Discrimination Scale (EoD) | 9.3 score on a scale | Standard Deviation 9.5 |
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.
Time frame: 12 months
Population: Ideal body image at 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Ideal Body Image | 3.9 score on a scale | Standard Deviation 1.1 |
| Intervention | Ideal Body Image | 3.5 score on a scale | Standard Deviation 0.9 |
| Intervention Male | Ideal Body Image | 4.1 score on a scale | Standard Deviation 1.2 |
| Control Male | Ideal Body Image | 3.9 score on a scale | Standard Deviation 0.9 |
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
Time frame: 12 months
Population: Total Score at 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | NIH Patient Reported Outcome Measurement Information System (PROMIS) Measure for Emotional Support | 63 Score on survey | Standard Deviation 13.8 |
| Intervention | NIH Patient Reported Outcome Measurement Information System (PROMIS) Measure for Emotional Support | 64.2 Score on survey | Standard Deviation 15 |
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
Time frame: 12 months
Population: Total score at 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Patient Health Questionnaire (PHQ) for Adults, PHQ-9 | 5.8 Total score on scale | Standard Deviation 4.9 |
| Intervention | Patient Health Questionnaire (PHQ) for Adults, PHQ-9 | 5.5 Total score on scale | Standard Deviation 4.2 |
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).
Time frame: Baseline to 12 months
Population: Intervention group who used app on or more than 80% of days to enter food
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Rate of Participants Who Are Adherent to Self-Monitoring | 40 Participants |
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.
Time frame: 12 months
Population: Total score at 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Self-Efficacy for Exercise Scale | 48.9 score on a scale | Standard Deviation 22.2 |
| Intervention | Self-Efficacy for Exercise Scale | 50.1 score on a scale | Standard Deviation 23.2 |
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
Time frame: 12 months
Population: Score at 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Treatment Self-Regulation Questionnaire (TSRQ) for Diet and Exercise | 59.7 Score on survey | Standard Deviation 11.3 |
| Intervention | Treatment Self-Regulation Questionnaire (TSRQ) for Diet and Exercise | 61.2 Score on survey | Standard Deviation 12.7 |