Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1U01HL096720 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Weight gain accelerates during early adulthood, and leads to the health consequences of obesity (high blood pressure, diabetes, heart disease, etc). Most weight loss studies enroll middle-aged adults. This study tests the hypothesis that a weight loss intervention that builds on prior research evidence but is enhanced with technological innovations will lead to weight loss in a diverse group of overweight and obese adults aged 18-35 years. The technology intervention, using cell phone applications, will be compared to an "advice only" control group and to a group receiving a more traditional personal coaching intervention.
Trials in middle aged adults indicate that weight loss can be achieved and sustained with frequent contact over a long period of time, frequent self-monitoring, social support and motivational counseling. However, it is unclear whether this strategy would work in younger adults. Based on life stage, cultural context, environmental circumstances, and marketing pressures, behavioral intervention may need to be substantially modified to be effective in young adults. Even more adaptation will be required for intervention to be effective in young adults from racial/ethnic minority groups. The proposed intervention builds on prior evidence with innovations directed at increasing effectiveness in young adults.
Using cell phones to deliver a weight control intervention in this age group has the potential to be engaging, enjoyable, practical, cost-effective, sustainable, and broadly disseminated. We propose a trial in which a highly innovative but more risky intervention based almost entirely on use of cell phone technology and a second more incremental innovation over traditional behavioral intervention are each compared to a usual care control group. We will recruit a diverse target population of overweight/obese, generally healthy young adults, comprising approximately 35% non-Latino Whites, 35% non-Latino Blacks, and 30% Latinos, to be randomized to: 1) Usual care control: Educational materials and information but no behavioral intervention; 2) Cell-phone intervention: similar education and knowledge as the control group, but thereafter a behavioral intervention will be delivered almost exclusively via cell phone, particularly using the self-monitoring and social networking features of this technology; 3) Personal contact with cell-phone enhancement: personal contact intervention enhanced by cell-phone for self-monitoring.
The post-randomization intervention period will last 24 months. The primary outcome is change in weight 12 months post-randomization; an important secondary outcome is weight change at 24 months.
The formative phase will focus largely on technology/intervention development.
To assess maintenance of weight loss, after completion of the primary outcome assessment (24 months post-randomization), participants in the control group are followed observationally; those in the cell-phone and personal coaching interventions are re-randomized to either continue intervention or stop intervention with observational follow-up. All participants who agree to participate in this maintenance phase are followed for an additional 2-3 years with data collection every 6-12 months.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cell phone intervention | Experimental | Behavioral lifestyle intervention for weight loss, delivered by cell phone. |
|
| Personal counseling intervention | Experimental | Behavioral lifestyle intervention for weight loss, delivered by personal counseling. |
|
| Advice only | No Intervention | Advice only control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral weight loss intervention | Behavioral | Behavioral lifestyle intervention for weight loss, compared to advice-only control. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Baseline and 24 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laura P Svetkey, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24462568 | Background | Batch BC, Tyson C, Bagwell J, Corsino L, Intille S, Lin PH, Lazenka T, Bennett G, Bosworth HB, Voils C, Grambow S, Sutton A, Bordogna R, Pangborn M, Schwager J, Pilewski K, Caccia C, Burroughs J, Svetkey LP. Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial - Cell Phone Intervention for You (CITY). Contemp Clin Trials. 2014 Mar;37(2):333-41. doi: 10.1016/j.cct.2014.01.003. Epub 2014 Jan 21. | |
| 26530929 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cell Phone Intervention | Behavioral lifestyle intervention for weight loss, delivered by cell phone. Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control. |
| FG001 | Personal Counseling Intervention | Behavioral lifestyle intervention for weight loss, delivered by personal counseling. Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control. |
| FG002 | Advice Only | Advice only control group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cell Phone Intervention | Behavioral lifestyle intervention for weight loss, delivered by cell phone. Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control. |
| BG001 | Personal Counseling Intervention |
| 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 | Intention to treat | Posted | Mean | Standard Deviation | kg | Baseline and 24 months |
|
24 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cell Phone Intervention | Behavioral lifestyle intervention for weight loss, delivered by cell phone. Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystectomy | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laura P. Svetkey | Duke University Medical Center | 919-660-6626 | laura.svetkey@dm.duke.edu |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Svetkey LP, Batch BC, Lin PH, Intille SS, Corsino L, Tyson CC, Bosworth HB, Grambow SC, Voils C, Loria C, Gallis JA, Schwager J, Bennett GG. Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology. Obesity (Silver Spring). 2015 Nov;23(11):2133-41. doi: 10.1002/oby.21226. |
| 26229119 | Background | Lin PH, Intille S, Bennett G, Bosworth HB, Corsino L, Voils C, Grambow S, Lazenka T, Batch BC, Tyson C, Svetkey LP. Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial. Clin Trials. 2015 Dec;12(6):634-45. doi: 10.1177/1740774515597222. Epub 2015 Jul 30. |
| 38375882 | Derived | Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2. |
| 30341051 | Derived | Lin PH, Grambow S, Intille S, Gallis JA, Lazenka T, Bosworth H, Voils CL, Bennett GG, Batch B, Allen J, Corsino L, Tyson C, Svetkey L. The Association Between Engagement and Weight Loss Through Personal Coaching and Cell Phone Interventions in Young Adults: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Oct 18;6(10):e10471. doi: 10.2196/10471. |
Behavioral lifestyle intervention for weight loss, delivered by personal counseling. Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control. |
| BG002 | Advice Only | Advice only control group. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | Kg/m^2 |
|
| Waist Circumference | Waist circumference is presented by gender. | Mean | Standard Deviation | cm |
|
| Dietary intake | The Healthy Eating Index (HEI) will be used to measure dietary intake. HEI assesses conformance to the Dietary Guidelines for Americans. HEI scores can range from 0 to 100, with 0 representing the least overall healthy diet, and 100 representing the most overall healthy diet. | Mean | Standard Deviation | Scores on the HEI scale |
|
| Physical activity | Mean | Standard Deviation | kcal/week |
|
| Advice Only |
Advice only control group. |
|
|
| 0 |
| 122 |
| 4 |
| 122 |
| 8 |
| 122 |
| EG001 | Personal Counseling Intervention | Behavioral lifestyle intervention for weight loss, delivered by personal counseling. Behavioral weight loss intervention: Behavioral lifestyle intervention for weight loss, compared to advice-only control. | 0 | 120 | 4 | 120 | 4 | 120 |
| EG002 | Advice Only | Advice only control group. | 0 | 123 | 5 | 123 | 1 | 123 |
| Psychiatric hospitalization | Psychiatric disorders | Systematic Assessment |
|
| Obstetric hospitalization | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|