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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK103863 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This research study will compare two weight loss programs that provide different recommendations for how to reduce your energy (or calorie) intake to achieve weight loss in an effort to determine if fixed calorie reduction or varied calorie reduction is more effective for weight loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed Energy (or Calorie) Reduction | Active Comparator | Participants randomly assigned to this arm will be instructed to reduce their food intake by a moderate amount and stay at this level of moderate reduction until their weight loss goal is achieved. |
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| Variable Energy (or Calorie) Reduction | Experimental | Participants randomly assigned to this arm will be instructed to alternate between two levels of calorie reduction. One level will be a small amount of calorie reduction, while the other will be a more significant amount of calorie reduction. At the instruction of the research team, participants will periodically alternate back and forth between these two goals until their weight loss goal is achieved. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energy Reduction | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Measure change in body weight (kg) from baseline to follow-up assessments | Participants will be weighed by body scale in kilograms | Baseline, 6 months, 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Resting energy expenditure | An indirect calorimeter with the ventilated hood technique will be used for the 30-minute measurement (the first 10 minutes will be excluded from analysis). The respiratory quotient will be calculated as the ratio of carbon dioxide production to oxygen consumption. Resting metabolic rate will be calculated from VO2 and VCO2 measurements using the Weir equation. | 6, 12, and 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gareth R Dutton, PhD | University of Alabama at Birmingham, Department of Medicine, Division of Preventive Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham, Medical Towers Building | Birmingham | Alabama | 35205 | United States |
The PI will ensure all publications that result from project-related data will comply with the NIH public access policy and develop a system by which study data may be shared with other investigators within the scientific community. With UAB IRB permission, PI may develop a de-identified database, codebook, and mechanism by which data can be shared with qualified individuals/organizations. PI will keep a record of all individuals/res. teams who request/receive a copy of the data. Interested investigators will be asked to complete a request form stating specific aims of the analyses, analytic plan, available resources, proposed timeline, and goals. PI and team will review these requests to determine whether proposed analyses constitute significant exploration of the data, team has resources to complete request, and data will be adequately protected and managed. If any issues are problematic, PI and team will attempt to negotiate a fair resolution with investigators and NIH staff.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D001835 | Body Weight |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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| Body composition | Assessed by full body DXA scan to evaluate percentage of body fat. | 6, 12, and 18 months |
| Laboratory analyses | Glucose, lipids, and insulin will be analyzed using blood samples. | 6, 12, and 18 months |
| Blood pressure | After a 5 minute seated rest, three measurements using an automated blood pressure device will be taken to obtain the average systolic and diastolic blood pressures. | 6, 12, and 18 months |
| Hormones - ghrelin | Total ghrelin will be assessed using blood samples. | 6, 12, and 18 months |
| Hormones - leptin | Total leptin will be assessed using blood samples. | 6, 12, and 18 months |
| Satiety/hunger | Visual analogue scales (VAS) will be used to measure subjective ratings of appetite. Participants will be asked to provide a rating in response to several questions (e.g., "How hungry did you feel this week? How much did you think about food this week?") using a 100-mm line ranging from "not at all" to "extremely". | 6, 12, and 18 months |
| Physical activity - objective | Will be assessed via accelerometers worn by participants for seven days. Participants will be instructed to position the accelerometer at the right hip and to wear the device throughout the day except when sleeping, bathing, or participating in swimming or other water activities. These data will be used to estimate total minutes of moderate- to vigorous-intensity PA. | 6, 12, and 18 months |
| Physical activity - self-report | Self-reported PA will also be assessed with the Paffenbarger Physical Activity Questionnaire (PPAQ). Both methods of PA measurement are included, as accelerometers provide objective information about total levels of activity, while the PPAQ provides additional details about the type and schedule of activities. | 6, 12, and 18 months |
| Treatment adherence | Treatment adherence will be assessed by the number of treatment sessions attended as well as the number of self-monitoring forms completed, which have both been used as indicators of adherence in our previous work | 6, 12, and 18 months |
| Treatment novelty | This construct will be evaluated with a 6-item measure of treatment reinforcement that assesses the extent to which participants enjoy and become less habituated to the behavioral strategies required for weight loss. | 6, 12, and 18 months |
| Treatment burden | Behavioral burden of treatment will be assessed with a modified version of the Treatment Burden Questionnaire (TBQ), which includes 15 items measuring the burden of treatment, including behaviors of self-monitoring, dietary changes, maintaining physical activity, and the impact of treatment on social relationships. | 6, 12, and 18 months |
| Treatment satisfaction | Participants will complete a modified version of the Treatment Satisfaction Questionnaire for Medication (TSQM) to assess attitudes and satisfaction regarding the weight loss intervention, energy prescriptions provided, and weight loss achieved. A composite score of treatment satisfaction will be calculated based on participants' responses. | 6, 12, and 18 months |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |