Obesity
Conditions
Keywords
Young adults
Brief summary
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.
Detailed description
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.
Interventions
Behavioral lifestyle intervention for weight loss, compared to advice-only control.
Sponsors
Study design
Eligibility
Inclusion criteria
* Age 18-35 years; * BMI \>=25; * Using a cellphone.
Exclusion criteria
* Diabetes mellitus; * Pregnant or nursing; * Use of weight loss medications, systemic steroids, antipsychotics, or diabetes medication; * Prior weight loss surgery; * Cardiovascular (CVD) event in past 6 months; * Current malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Body Weight | Baseline and 24 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 122 |
| 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. | 120 |
| Advice Only Advice only control group. | 123 |
| Total | 365 |
Baseline characteristics
| Characteristic | Personal Counseling Intervention | Advice Only | Cell Phone Intervention | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 120 Participants | 123 Participants | 122 Participants | 365 Participants |
| Age, Continuous | 29.4 years STANDARD_DEVIATION 4.3 | 29.6 years STANDARD_DEVIATION 4.3 | 29.2 years STANDARD_DEVIATION 4.2 | 29.4 years STANDARD_DEVIATION 4.3 |
| BMI | 34.9 Kg/m^2 STANDARD_DEVIATION 7.5 | 35.1 Kg/m^2 STANDARD_DEVIATION 7.5 | 35.7 Kg/m^2 STANDARD_DEVIATION 8.2 | 35.2 Kg/m^2 STANDARD_DEVIATION 7.8 |
| Dietary intake | 50.8 Scores on the HEI scale STANDARD_DEVIATION 3.6 | 50.7 Scores on the HEI scale STANDARD_DEVIATION 4.4 | 51.6 Scores on the HEI scale STANDARD_DEVIATION 4.2 | 51.0 Scores on the HEI scale STANDARD_DEVIATION 4.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 5 Participants | 9 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 113 Participants | 118 Participants | 113 Participants | 344 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Physical activity | 1009.3 kcal/week STANDARD_DEVIATION 1346.4 | 865.9 kcal/week STANDARD_DEVIATION 1133.9 | 756.0 kcal/week STANDARD_DEVIATION 846.1 | 879.7 kcal/week STANDARD_DEVIATION 1134.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 5 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 48 Participants | 42 Participants | 42 Participants | 132 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) White | 65 Participants | 70 Participants | 68 Participants | 203 Participants |
| Region of Enrollment United States | 120 Participants | 123 Participants | 122 Participants | 365 Participants |
| Sex: Female, Male Female | 85 Participants | 85 Participants | 84 Participants | 254 Participants |
| Sex: Female, Male Male | 35 Participants | 38 Participants | 38 Participants | 111 Participants |
| Waist Circumference Females | 107.4 cm STANDARD_DEVIATION 16.4 | 107.9 cm STANDARD_DEVIATION 15.7 | 109.3 cm STANDARD_DEVIATION 18.4 | 108.2 cm STANDARD_DEVIATION 16.8 |
| Waist Circumference Males | 111.5 cm STANDARD_DEVIATION 16.4 | 109.8 cm STANDARD_DEVIATION 14.6 | 113.8 cm STANDARD_DEVIATION 17.9 | 111.7 cm STANDARD_DEVIATION 16.3 |
| Weight | 99.3 kg STANDARD_DEVIATION 23.4 | 101.3 kg STANDARD_DEVIATION 22.6 | 102.4 kg STANDARD_DEVIATION 25.2 | 101.0 kg STANDARD_DEVIATION 23.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 122 | 0 / 120 | 0 / 123 |
| other Total, other adverse events | 8 / 122 | 4 / 120 | 1 / 123 |
| serious Total, serious adverse events | 4 / 122 | 4 / 120 | 5 / 123 |
Outcome results
Change in Body Weight
Time frame: Baseline and 24 months
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cell Phone Intervention | Change in Body Weight | -0.99 kg | Standard Deviation 6.2 |
| Personal Counseling Intervention | Change in Body Weight | -2.6 kg | Standard Deviation 6 |
| Advice Only | Change in Body Weight | -1.7 kg | Standard Deviation 8.3 |