Lowering Caloric Density of the Diet
- Conditions
- ObesityFeeding Behavior
- Interventions
- Behavioral: Common components of intervention
- Registration Number
- NCT02674971
- Lead Sponsor
- The University of Tennessee, Knoxville
- Brief Summary
For weight loss to occur, energy intake needs to be reduced to incur an energy deficit. One dietary strategy that may facilitate reducing energy intake and enhancing weight loss is consuming a diet low in dietary energy density (ED). The ED of a given food, defined as the ratio of energy of the food to the weight of the food (kcal/g), is largely determined by water content, but is also affected by fat and fiber. Although the 2010 Dietary Guidelines encourage an eating pattern low in energy density (ED) to manage weight, it is currently not known what the best strategy is for reducing ED in the diet. Eating a greater number of foods low in ED or reducing the number of foods high in ED may reduce overall dietary ED. As ED is believed to reduce intake by allowing a greater weight of food relative to total energy consumed assisting with enhancing feelings of fullness, it is anticipated that either increasing consumption of low-ED foods in the diet alone or combining an increase in consumption of low-ED foods with a decrease in consumption of high-ED foods may be the best strategies for reducing overall dietary ED for weight loss.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
-
- age between 18 and 65 years and 2) a body mass index (BMI)7 between 27 and 45 kg/m2.
- report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q)8 (medical conditions that could limit exercise for safety reasons will be required to obtain written physician consent before participating in the investigation)
- report being unable to walk for 2 blocks (1/4 mile) without stopping
- are currently participating in a weight loss program and/or taking weight loss medication or lost > 5% of body weight during the past 6 months
- report major psychiatric diseases or organic brain syndromes
- have had bariatric surgery or are planning to have bariatric surgery within the next 4 months
- intend to move outside of the metropolitan area within the time frame of the investigation
- are pregnant, lactating, < 6 months post-partum, or plan to become pregnant during the investigation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INCREASE Common components of intervention This condition will be instructed to make food consumption decisions based solely upon the ED of a food. The goal of the ED condition will be to consume at least 10 foods ≤ 1.0 kcal/g (i.e., fruits and vegetables, broth based soups, non-fat yogurts, some legumes, egg substitutes, some white fish, etc.) per day. COMBINATION Common components of intervention This condition will be identical to the INCREASE condition, except it will also have a goal regarding the number of high-ED foods to consume and substituting low-ED foods for high-ED foods. Thus, this condition will have ED goals to consume at least 10 foods ≤ 1.0 kcal/g (i.e., fruits and vegetables, broth based soups, non-fat yogurts, some legumes, egg substitutes, some white fish, etc.) and no more than 2 foods ≥ 3.0 kcal/g (i.e., crackers, chips, cookies, hard cheeses, hot dogs, salad dressings, etc.) per day. Foods with an ED \>1.0 kcal/g but \< 3.0 kcal/g will be unlimited; however, lower ED foods will be strongly encouraged. Furthermore, additions to beverages (i.e., sugar, cream) will count toward the \> 3.0 kcal/g goal if the additions meet that ED criteria.
- Primary Outcome Measures
Name Time Method Dietary: Macronutrients change from baseline to 12 weeks Changes in overall dietary intake and changes per eating bout will be assessed by 3 day (2 weekdays and 1 weekend) food records. To determine dietary variables, each food record will be entered into the Nutrition Data System for Research (NDS-R) software developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.
Physical activity change from baseline to 12 weeks Changes in self-reported physical activity will be determined by the Paffenbarger Activity Questionnaire (PAQ).16 This questionnaire yields estimates of the total energy expended in PA per week based on flights of stairs climbed per day, city blocks walked per day, and hours of structured activity acquired within a typical week. The PAQ has been shown to be significantly correlated with an objective measure of PA.
Dietary: Grams of Intake change from baseline to 12 weeks Changes in overall dietary intake and changes per eating bout will be assessed by 3 day (2 weekdays and 1 weekend) food records. To determine dietary variables, each food record will be entered into the Nutrition Data System for Research (NDS-R) software developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.
Dietary: Energy Density change from baseline to 12 weeks Changes in overall dietary intake and changes per eating bout will be assessed by 3 day (2 weekdays and 1 weekend) food records. To determine dietary variables, each food record will be entered into the Nutrition Data System for Research (NDS-R) software developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.
Dietary: Fiber change from baseline to 12 weeks Changes in overall dietary intake and changes per eating bout will be assessed by 3 day (2 weekdays and 1 weekend) food records. To determine dietary variables, each food record will be entered into the Nutrition Data System for Research (NDS-R) software developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.
BMI change from baseline to 12 weeks Change in BMI (kg/m2) will be calculated from height and weight measures.
Height baseline Height will be assessed by stadiometer, using standard procedures.
Dietary: Energy Intake change from baseline to 12 weeks Changes in overall dietary intake and changes per eating bout will be assessed by 3 day (2 weekdays and 1 weekend) food records. To determine dietary variables, each food record will be entered into the Nutrition Data System for Research (NDS-R) software developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.
Ecological Momentary Assessment (EMA) change from baseline to 12 weeks (EMA) refers to a collection of methods often used in behavioral medicine research by which a research participant repeatedly reports on symptoms, affect, behavior, and cognitions close in time to experience and in the participants' natural environment. EMA protocol will be conducted over 7 continuous days using both semi-random and event-contingent sampling. Semi-random responses will be collected at varied times within three windows (morning, afternoon, and evening), with three assessments occurring per day triggered by an alarm prompt that signals a 30-minute window for response. Event-based sampling will be used to assess eating bouts. Semi-random sampling will assess consumption cues (i.e. feelings of temptation, fullness, desire to eat, energy level and control over eating), along with feelings of hunger, satiation, and deprivation using a series of 11 questions.
Weight change from baseline to 12 weeks Change in weight will be assessed by an electronic scale, using standard procedures.
- Secondary Outcome Measures
Name Time Method Diet satisfaction 12 weeks The Food Acceptability Questionnaires will assess acceptability and satisfaction of diet at 12 weeks. Participants will be asked about ease of following the diet, ease of determining foods to consume to meet dietary goals, and ease of reading food labels to select foods to consume to meet dietary goals (which is all one questionnaire).
Trial Locations
- Locations (1)
Healthy Eating and Activity Laboratory, University of Tennessee
🇺🇸Knoxville, Tennessee, United States