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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK137423 | 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 project capitalizes on principles of control systems engineering to build a dynamical model that predicts weight change during weight loss maintenance using behavioral, psychosocial, and environmental indicators evaluated in a system identification experiment. A 6-month behavioral obesity treatment will be administered to produce weight loss. Participants losing at least 3% of initial body weight will be followed for an additional 12 months via daily smartphone surveys that incorporates passive sensing to objectively monitor key behaviors. Survey data pertaining to behavioral, psychosocial, and environmental indicators will be used to develop a controller algorithm that can predict when an individual is entering a heightened period of risk for regain and why risk is elevated. Interventions targeting key risk indicators will be randomly administered during the system ID experiment. Survey and passive sensing data documenting the effects of the interventions will likewise drive development of the controller algorithm, allowing it to determine which interventions are most likely to counter risk of regain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| System Identification | Experimental | All participants who lose at least 3% of their initial body weight will be asked to participate in a system identification experiment every day for 52 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Targeting Stress and Emotion Regulation | Behavioral | This intervention involves learning and practicing relaxation exercises and setting aside time for pleasurable activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight change | This will be measured throughout the system identification experiment using a consumer scale with internet connectivity. | Every day during the 52-week system identification experiment |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention engagement | Intervention engagement will be measured by the smartphone application that delivers intervention. Engagement is defined as the count of clicks to open intervention resources. | Every day during the 52-week system identification experiment |
| Weight Locus of Control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharon O'Toole, M.A.T. | Contact | 401 793-8992 | sotoole@lifespan.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miriam Hospital Weight Control and Diabetes Resarch Center | Recruiting | Providence | Rhode Island | 02903 | United States |
We will make data and documentation available under a data-sharing agreement that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology; (3) a commitment to destroying or returning the data after analyses are completed and (4) a commitment not to attempt to identify participants individually. Information shared with outside collaborators will link personal health information to a unique study ID in order to maintain participant anonymity.
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A data-sharing agreement that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology; (3) a commitment to destroying or returning the data after analyses are completed and (4) a commitment not to attempt to identify participants individually. Information shared with outside collaborators will link personal health information to a unique study ID in order to maintain participant anonymity.
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See study description for details. All participants will receive all intervention elements, with allocation varying randomly across time using procedures appropriate for system identification.
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| Intervention Targeting Motivation and Self-efficacy for Weight Management | Behavioral | This intervention involves identifying values related to weight, lifestyle, and health; identifying barriers to value-consistent living; exploring the consequences of letting barriers drive behavior; and 4) setting goals that are small, specific, attainable, and values-consistent. |
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| Intervention for Normalization of Eating | Behavioral | This intervention involves dietary self-monitoring with the goal of staying within a calorie goal ranging from 1,200 kcal/day to 1,800 kcal/day. Participants are also provided with meal planning tools and encouraged to addresses hunger and cravings by promoting feelings of satiety via consumption of foods that are high in volume but low in calories. |
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| Intervention Targeting Physical Activity and Sleep | Behavioral | This simple intervention prompts participants at the start of the day to schedule up to 30 minutes of moderate-to-vigorous intensity physical activity; brisk walking is encouraged. Participants also set a bedtime and wake time and are encouraged to set a reminder alarm to ensure at least 8 hours of sleep. |
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Mean scale score of questionnaire items adapted from the Multidimensional Health Locus of Control scale for smartphone administration. |
| Every day during the 52-week system identification experiment |
| Perceived Benefit of Weight Control | Mean scale score of questionnaire items adapted from the Beliefs about Dietary Compliance Scale and the Exercise Benefits/Barriers scale for smartphone administration. | Every day during the 52-week system identification experiment |
| Weight Control Strategies Intentions and Implementation | Mean scale score of questionnaire items adapted from the Weight Control Strategies scale for smartphone administration. | Every day during the 52-week system identification experiment |
| Hunger and Cravings | Mean scale score of questionnaire items adapted from the Three Factor Eating Questionnaire for smartphone administration. | Every day during the 52-week system identification experiment |
| Affect | Mean scale score of questionnaire items adapted from the Profile of Mood States and Positive and Negative Affect States for smartphone administration. | Every day during the 52-week system identification experiment |
| Stress | Mean scale score of questionnaire items adapted from Cohen's Stress Scale for smartphone administration. | Every day during the 52-week system identification experiment |
| Self-efficacy | Mean scale score of questionnaire items adapted from the short-form Weight Efficacy Lifestyle Questionnaire for smartphone administration. | Every day during the 52-week system identification experiment |
| Sleep | Wrist-worn accelerometer-measured sleep timing, duration & quality. | Every day during the 52-week system identification experiment |
| Social Support | Mean scale score of questionnaire items adapted from the short-form Multidimensional Scale of Perceived Social Support for smartphone administration. | Every day during the 52-week system identification experiment |
| Physical Activity | Wrist-worn accelerometer-measured minutes per day of physical activity. | Every day during the 52-week system identification experiment |
| Dysregulated Eating | Mean scale score of questionnaire items adapted from the Three Factor Eating Questionnaire for smartphone administration. | Every day during the 52-week system identification experiment |
| Dietary Lapse | Count of self-reported instances of unintended eating, eating larger portions than one intended, and eating foods that one intended to avoid | Every day during the 52-week system identification experiment |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D012890 | Sleep |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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